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Full text of "California Code of Regulations, (Vol. 22), Title 17, Public Health"

.^IL 



Barclays Official 

California 

Code of 
Regulations 



• 



Title 17. Public Health 

Complete Title 



Vol. 22 



XHOr/ISOINJ 

^ 

\A/EST 



Barclays Official California Code of Regulations 

425 Market Street • Fourth Floor • San Francisco, CA 94105 
800-888-3600 



Barclays Official California Code Of Regulations 

REVISED edition 

This edition of Barclays Official California Code of Regulations, revised on April 1, 1990, has been 
published under the direction of the California Office of Administrative Law which is solely respon- 
sible for its contents. Comments or questions regarding regulations published in this edition should 
be addressed to the State of California, Office of Administrative Law, 300 Capitol Mall, Suite 1250, 
Sacramento, CA 95814, (916) 323-6225. Errors reported will be promptly corrected in subsequent 
supplements. 

OFFICIAL PUBLICATION 

Courts are required to take judicial notice of contents of regulations published in the Official Califor- 
nia Code of Regulations (Gov. Code, § 11344.6). Barclays Official California Code of Regulations, 
as revised April 1 , 1990, has been certified by the Office of Administrative Law as the official publi- 
cation of the State of California for this purpose pursuant to title 1, California Code of Regulations, 
section 190. 

CODE SUPPLEMENTS 

Amendments to the official Code are certified weekly by the Office of Administrative Law for publi- 
cation by Barclays. These amendments, when certified and published, become part of the Official 
California Code of Regulations, beginning with Register 90, No. 14, dated April 7, 1990, and include 
all regulations filed with the Secretary of State on or after April 1, 1990. Amendment subscriptions 
to the entire revised Code, or to parts of it, are available from the publisher. For a descriptive bro- 
chure and order form, write Barclays Official California Code of Regulations, RO. Box 2008, San 
Francisco, CA 94126 or telephone 800-888-3600. 

CODE CITATION 

Cite all materials in the Official California Code of Regulations by title number and section number. 
Example: Title 3, California Code of Regulations, section 432 (Short form: Cal. Code Regs., tit. 3, 

§ 432). 

COPYRIGHT NOTICE 

© 2008, State of California. 

This material may not be commercially reproduced or sold in print or electronic forms without 

written permission of ThomsonAVest. 



• 



TITLE 17. PUBLIC HEALTH 



NOMENCLATURE CROSS-REFERENCE 



(NOTE: Effective April 1 , 1 990, the Office of Administrative Law authorized the renaming of the 
hierarchical headings used within the Titles of the California Code of Regulations. Until the agen- 
cies implement these changes in their regulations, use the following Cross-Reference Table for 
the new organizational headings used in this Title.) 



OLD HIERARCHY REVISED HIERARCHY 

Part Division 

Chapter Chapter 

Subchapter Subchapter 

Group Group 

Subgroup Subgroup 

Article Article 

Part Subarticle 

Section Section 



Title 17 



Public Health 



Title Table of Contents 



Title 17. Public Health 



Table of Contents 



Division 1. 

Chapter 1 . 
Subchapter 1. 

Subchapter 2. 

Article 1. 

Subchapter 3. 

Group 1. 

Group 2. 

Subgroup 2 

Group 3. 
Group 4. 

Group 5. 
Subchapter 4. 
Article 1. 



Article 2. 

Article 3. 

Article 4. 

Subchapter 5. 

Chapter 2. 
Subchapter 1. 
Group 1. 

Article 1. 
Article 2. 
Article 3. 



Page 

State Department of Health 

Services i 

Administration i 

State Department of 

Health Services i 

Hospital Districts l 

Liability Loans i 

Hospital Inspection i 

Clinics and Dispensaries 2 

Health Facilities 2 

Requirements for Outpatient 

Clinics 2 

Nonprofit Hospitals 2 

Establishments for Handicapped 
Persons 2 

Public Medical Institutions 2 

Records and Statistics 2 

Access to the Records in the 

Office of the State 

Registrar and in the 

Offices of Local 

Registrars 2 

Late Registration of Births 

and Deaths 3 

Birth Certificates of 

Deceased Persons 3 

Definitions of Live Birth 

and Fetal Death 3 

Home Health Agency 

Licensing Requirements 4 

Laboratories 4 

Service Laboratories 4 

Production and Distribution of 
Biologies 4 

Licenses 4 

Exemptions 4 

Inspection and Records 4 



Page 

Article 4. Storage 5 

Article 5. Containers and Labeling 5 

Article 6. Advertising 5 

Article 7. Samples 5 

Article 8. Vaccine Culture ? 

Article 9. Preparation and Distribution 

of Whole Blood (Human) 3 

Article 10. Preparation and Distribution 

of Normal Human Plasma 8 

Article 1 1 . Preparation of Other Blood 

Derivatives 8 

Article 12. Transportation of Etiologic 

Agents 9 

Article 1 3. Research Projects 9 

Group 2. Clinical Laboratory 

Regulations 9 

Article 1 . Definitions 9 

Article 1.5. Licensure of Clinical 

Laboratory Personnel 19 

Article 2. Training 20.10 

Article 2.3. Clinical Laboratory 

Supervisors 20.13 

Article 2.5. Confinuing Education 20.1? 

Article 2.8. CLIA Certification/State 

Licensure 22 

Article 3. License 22 

Article 4. Personnel Report 22.1 

Article 5. Issuance of License 22.1 

Article 5.2. Test Kits Approved for Over- 
the-Counter Sale to the 
Public by the United States 
Food and Drug 
Administration 22.3 

Article 5.3. Blood Electrolyte Analysis 
by Respiratory Care 
Practitioners 22.4 

Article 5.5. Use of Poini-of-Carc 

Laboratory Testing Devices 

by Registered Nurses 22.4 



Page i 



Title Table of Contents BARCLAYS CALIFORNIA 

Page 

Article 5.6. Moderately Complex 
Laboratory Testing by 
Licensed Psychiatric 
Technicians. Licensed 
Vocational Nurses, Licensed 
Midwives, Certified Nurse 
Assistants, and Certified 
Home Health Aides 22.4(a) 

Article 6. Laboratory Reports 22.4(a) 

Article 7. Cytotechnology 22.4(b) 

Article 8. Enforcement 22.5 

Group 3. County and Municipal 

Laboratories 22. 1 1 

Article 1 . Official Public Health 
Laboratory Service 
Required 22.11 

Group 4. Tests for Syphilis Under the 

Premarital and Prenatal Laws 23 

Article 1 . Serologic Tests 23 

Group 5. Care of Laboratory Animals 24 

Article 1. Definitions 24 

Article 2. Certification Requirements 25 

Article 3. Minimum Standards 25 

Article 4. Filing of Complaint 26 

Group 5.5. Methadone Drug Analysis 

Laboratories 26 

Article 1 . Application 26 

Article 2. Definitions 26 

Article 3. Requirements for Methadone 

Drug Analysis Laboratories 26 

Article 4. Licensing Procedures 27 

Article 5. Substances Approved for 
Analysis, Requirements for 
Collection and Handling of 
Samples 27 

Article 6. Methods of Analysis and 

Standards of Performance 28 

Article 7. Inspections, Quality 
Control, Proficiency 
Testing 28 

Article 8. Records 29 

Group 6. Water Laboratories 29 

Group 7. Human Tissue Preservation 29 

Article 1. Approval 29 

Group 8. Forensic Alcohol Analysis and 

Breath Alcohol Analysis 30 

Article 1 . General 30 



CODE OF REGULATIONS Title 17 

Page 

Article 2. Requirements for Forensic 

Alcohol Laboratories 30 

Article 3. Licensing Procedures 31 

Article 4. Training of Personnel 32 

Article 5. Collection and Handling of 

Samples 32 

Article 6. Methods of Forensic Alcohol 

Analysis 33 

Article 7. Requirements for Breath 

Alcohol Analysis 34 

Article 8. Records 35 

Group 9. HIV Antibody Testing 35 

Article 1 . Approval of Laboratories 35 

Chapter 3. Local Health Service 36 

Subchapter 1 . Standards for State Aid 
for Local Health 
Administration 36 

Article 1 . Organization 36 

Article 2. Program 37 

Article 3. Personnel 38 

Article 4. Finance 40 

Subchapter 2. Standards for State Aid 
for Comprehensive 
Environmental Agencies 41 

Article 1 . Definitions 41 

Article 2. Agency Personnel and 

Facilities 41 

Article 3. Organization 41 

Article 4. Program 42 

Subchapter 3. Standards for Maintaining 

County Health Services 42 

Article 1 . Application 42 

Article 2. Definitions 43 

Article 3. County Health Services 

Multi-Year Plan and Budget 46 

Article 4. Allocations, Agreement, 

Disbursement, Reporting and 
Recoupment Procedures 47 

Article 5. Public Hearing Procedures 50 

Article 6. County Medical Services 

Program 50 

Chapter 3.1. Indian Health 51 

Article 1. Definitions 51 

Article 2. Indian Health Policy Panel 52 

Article 3. Assistance to Indian Health 

Programs 52 

Article 4. Standards of Service 53 



Page ii 



(7-25-2008) 



Title 17 



Public Health 

Page 

Joint Regulations for Article 3. 

Handicapped Children 59 

Interagency Article 4. 

Responsibilities for Subchapter 5. 

Providing Services to Group 1 

Handicapped Children 59 

Article 1. 

Preventive Medical Service 59 

Reportable Diseases and Group 2. 

Conditions 59 Subchapter 6. 

Reporting 59 

General Instructions 66 

„ -r- TA- T Subchapter?. 

Specific Diseases and 

Conditions 67 Subchapter 8. 

Reporting of Human 

Immunodeficiency Virus 

(HIV) Infection 76.2 

1 . Definitions 76.2 

4. Reporting Requirements 76.4 

Approval Procedures for 

Canine Rabies Vaccines 76.6 Article 1 . 

Adult Health 76.8 Article 2. 

Disorders Characterized Article 3. 

by Lapses of 

Consciousness 76.8 

Definitions 76.8 

Reporting 76.8 Article 4. 

Services for Physically Article 5 

Handicapped Children 76.8 

Minimum Standards for the Care Subchapter 8.1. 

of Physically Handicapped 

Children for Local Subchapter 8.2. 

Communities in California 76.8 

General 76.8 

Immunization Adverse Subchapter 9. 

Reaction Fund 76.9 

Podiatrist and Family Group 3. 

Practice Physician Article 1 

S^^^^^^^ ''-^ Article2. 

Genetically Handicapped 

Persons Program 76.10 Article 3 

Registration as School Article 4 

Audiometrists 77 

General 77 Group 5. 

The Infant Botulism 

Treatment and Prevention Article 1 . 

P^^g^^"^ '^-^ Article3. 

Definitions 78.1 

Distribution of Botulism Article 4. 

Immune GlobuUn 78.1 



Title Table of Contents 

Page 

Reporting Requirements for 
Hospitals Receiving BIG 78.1 

Fees 78.1 

Public Health Nursing 79 

Public Health Nursing 79 

Issuance of Public Health 

Nursing Certificates 79 

Trained Attendants 79 

Tuberculosis Hospitals 

and Sanatoria Receiving 

State Subsidy 79 

Venereal Diseases 79 

Immunization Against 

Poliomyelitis, 

Diphtheria, Pertussis, 

Tetanus, Measles 

(Rubeola), Rubella, 

Haemophilus Influenzae 

Type B (Hib), Mumps, and 

Hepatitis B 79 

Definitions 79 

Required Immunizations 80 

Admission to School, Child 

Care Center, Day Nursery, 

Nursery School, Family Day 

Care Home, or Development 

Center 82 

Exclusion 85 

Records As Evidence of 
Immunization 86 

Immunization Against 

Measles (Rubeola) 87 

Immunization Against 

Diphtheria, Tetanus, and 

Pertussis 87 

Testing for Heritable 

Disorders 87 

Newborn Screening Program 87 

Definitions 87 

Testing and Follow-Up 

Program Requirements 89 

Sickle Cell Programs 92 

Newborn Screening 

Participation Fee 93 

Prenatal (Multiple Marker) 

Testing Program 94 

Definitions 94 

Testing and Follow Up 

Program Requirements 94.2 

Prenatal Screening Fee 

Collection 94.3 



Chapter 3.5. 
Subchapter 1 . 



Chapter 4. 
Subchapter 1 . 

Article 1. 
Article 2. 
Article 3. 

Article 3.5. 

Subarticle 
Subarticle 
Article 4. 

Subchapter 2. 
Subchapter 2.5. 

Article 1. 

Article 2. 

Subchapter 3. 

Group 1. 



Article 1. 
Article 2. 

Article 3. 

Article 4. 

Group 2. 

Article 1. 
Subchapter 4. 

Article 1. 
Article 2. 



Page iii 



Title Table of Contents BARCLAYS CALIFORNIA 

Page 

Subchapter 10. Tuberculosis Screening of 
Employees and Volunteers 
in Private, Parochial 
and Nursery Schools 94.4 

Article 1 . Definitions 94.4 

Article 2. Records as Evidence of 

Compliance 94.4 

Subchapter 1 1 . First Aid and 

Cardiopulmonary 

Resuscitation Training 

Standards for Public 

Safety Personnel 94.4 

Article 1. General 94.4 

Article 2. Definitions 94.4 

Article 3. Training Standards 94.4 

Article 4. Designated Agencies 95 

Subchapter 12. Ambulance Personnel 95 

Subchapter 13. Child Health and 

Disability Prevention 

Program 95 

Article 1 . Definitions 95 

Article 2. Program Administration 97 

Article 3. Eligibility for Services and 

Reimbursement 99 

Article 4. Required Services 100 

Article 5. Providers of Health 

Screening and Evaluation 

Services 104 

Article 6. Claiming for Services 105 

Article 7. Records, Reporting and 

Confidentiality 106 

Subchapter 14. Stop Tobacco Access to 

Kids Enforcement (STAKE) 

Act Program 107 

Chapter 5. Sanitation (Environmental) 108.1 

Subchapter 1. Engineering (Sanitary) 108.1 

Group 1. Domestic Water Supplies 

Quahty and Monitoring 108.1 

Group 1.1. Waterworks Standards 108.1 

Group 2. Certification of Water 

Treatment Facihty Operators 108.1 

Article 1. General 108.1 

Article 2. Responsibility of Water 

Supplier 108.1 

Articles. Responsibility of Operators 108.1 

Article 4. Issuance of Certificates 108.1 

Article 5. Types of Certification 108.2 



CODE OF REGULATIONS Title 17 

Page 

Article 6. Certification Issuance, 

Renewal, Suspension and 
Revocation 108.2 

Article 7. Examination 108.3 

Article 8. Fees 108.3 

Group 3. Drain Wells 108.4 

Article 1 . Drain Wells 108.4 

Group 4. Drinking Water Supplies 109 

Article 1 . General 109 

Article 2. Protection of Water System 11 

Article 3. Protection of Public Water 
System at Service 
Connection 112 

Article 4. Protection of Potable Water 

System Within Premises 112 

Article 5. Domestic Water Supply 

Reservoirs 112 

Article 1 1 . Delegation of Authority 

Pursuant to Section 4025 of 
the Health and Safety Code 
(Permits for Small Water 
Systems) 113 

Article 12. Production and Distribution 

of Bottled Water 113 

Group 5. Sanitary Control of Shellfish 113 

Article 1 . Shellfish Certificates 1 13 

Article 2. Safety of Shellfish and 

Health of Employees 114 

Article 3. Records 114 

Article 4. Shellfish Beds 114 

Article 5. Plants and Operations 114 

Group 6. Pubhc Swimming Pools 116 

Group 7. Bottled Water and Water 

Vending Machines 116 

Article 1 . Water Bottler and Water 

Vendor Responsibilities 116 

Article 2. Definitions 116 

Article 3. Water Quality 116 

Article 4. Good Manufacturing 

Practices 116 

Article 5. Out-of-State Bottler or 

Distributor 117 

Article 6. Licenses and Fees 117 

Group 8. Sanitary Inspections 118 

Article 1. Sale of Rat Exterminators 118 

Article 2. Capture, Holding, Shipment 

and Sale of Wild Rodents 118 

Group 9. Registered Sanitarians GTP 119 



Page iv 



(7-25-2008) 



Title 17 



Public Health 

Page 

Internship Program 119 

Approval of Educational 

Institutions 1 19 

Registration Procedures 119 

Minimum Educational and 
Experience Qualifications 
for Admission to the 
Examination for Registered 
Sanitarians 119 

Application Procedures for 
Sanitarian Registration 120 

Sanitation, Healthfulness and 
Safety of Ocean Water-Contact 
Sports Areas 120 

Intent of Regulations 120 

Definitions 120 

Sanitation 120 

Healthfulness 120 

Safety 121 

Sanitation of Public Beaches 121 

Intent of Regulations 121 

Definitions and Exemptions 121 

Day Use Beaches 122 

Beaches Allowing Overnight 
Camping 122.1 

Food Crop Growing and 

Harvesting Sanitation 123 

Intent of Regulations 123 

Definitions 123 

Toilet Facilities 123 

Servicing of Units 123 

Supplies 124 

Handwashing Facilities 124 

Waste Wash Water Disposal 124 

Reclaimed Waste Water 124 

Regulations for 

Implementation of the 

California Environmental 

Quality Act of 1970 124 

Foods and Drugs 124 

Rules and Regulations 124 

Definitions 125 

Drugs and Devices 

Regulations 125 

Food Regulations 132 

Food Additives Regulations 134 



Title Table of Contents 

Page 

Foods Under Agricultural 

Code Regulations 1 34 

Poultry Meat and Poultry 

Products 1 34 

Raw Milk and Raw Milk 

Products 134.1 

Horse Meat Regulations 1.34.1 

Cold Storage Regulations 134.1 

Low Acid Frozen Foods in 

Hermetically Sealed 

Containers, Regulations 1.34.1 

Bakery Sanitary Regulations ... 1.34.1 

Local Enforcement of the 

Sherman Food, Drug and 

Cosmetic Law As It Relates 

to Retail Food 

Establishments 135 

Food Sanitation Regulations 136 

Cannery Inspection 

Regulations 138 

Olive Oil Regulations 152 

Mobile Food Preparation 

Units 152 

Commissaries Servicing 
Mobile Food Preparation 
Units 155 

Requirements for the Sale of 

Imitation Hamburger in 

Restaurants 155 

Requirements for Roadside 

Stands, Food Establishments 

Open to the Outside Air, 

and Retail Dairies 155 

Ventilation Standards for 

Retail Food Establishments 156 

Raw Oysters 156 

Frozen Food Locker 

Regulations 156.3 

Hazardous Substances 

Regulations 157 

Definitions and Standards 157 

Food Standards 157 

Flour and Cereal 

Products 157 

Corn Flour and Related 

Products 157 

Rice and Related 

Products 157 

Bakery and Bakery 

Products 157 



Article 1. 
Article 2. 

Article 3. 
Article 4. 



Article 5. 
Group 10. 

Article 1. 
Article 2. 
Article 3. 
Article 4. 
Article 5. 
Group 10.1. 
Article 1. 
Article 2. 
Article 3. 
Article 4. 

Group 11. 

Article 1. 
Article 2. 
Article 3. 
Article 4. 
Article 5. 
Article 6. 
Article 7. 
Group 12. 
Subchapter 1.5. 



Subchapter 2. 
Group 1. 
Article 1. 
Article 2. 

Article 3. 
Article 3.1. 



Article 3.5. 

Article 3.6. 

Article 3.7. 

Article 4. 
Article 5. 
Article 5.5. 

Article 6. 
Article 6.1. 



Article 7. 
Article 8. 

Article 9. 
Article 10. 

Article 10.1. 
Article 10.2. 
Article 10.3. 

Article 10.4. 

Article 10.5. 
Article 11. 

Article 12. 

Group 2. 
Article 13. 
Subarticle 

Subarticle 

Subarticle 

Subarticle 



2A 



Page V 



Title Table of Contents BARCLAYS CALIFORNIA 

Page 

Subarticle 4. Alimentary Pastes 157 

Subarticle 1. Canned Vegetables 158 

Subarticle 2. Canned Vegetable Other 
Than Those Specifically 
Regulated 158 

Subarticle 3. Canned Tomatoes 158 

Subarticle 4. Tomato Products 158 

Subarticle 5. Tomato Products, Mold 

Filament Tolerance 158 

Subarticle 1 . Canned Fruit 158 

Subarticle 2. Fruit Preserves and 

Jellies 158 

Subarticle 3. Fruit Butters 158 

Subarticle 3.5. Citrus Products 158 

Subarticle 4. Carbonated Beverages 158 

Subarticle 1. Dressings for Salads 159 

Subarticle 1 . Canned Shrimp 159 

Subarticle 2. Canned Oysters 159 

Subarticle 3. Raw Oysters 159 

Subarticle 4. Sea Food Cocktails 159 

Subarticle 5. Canned Tuna Fish 159 

Subarticle 1 . Extracts 160 

Subarticle 2. Flavors 160 

Subarticle 3. Labeling 160 

Subarticle 1. Olives, Ripe, Sold in 

Bulk 161 

Subarticle 2. Canned Whole and Pitted 

Ripe Ohves 161 

Article 13.1. Actionable Defect Levels for 

Processed Foods 163 

Article 14. Wine Standiu-ds and 

Prohibited Practices 163 

Article 15. Distilled Spirits Standards 164 

Article 16. Processed Pet Food 

Regulations 165 

Subchapter 3. Vector Control 167 

Group 1 . Standards Governing State Aid 
to Local Mosquito Control 
Agencies 167 

Group 2. Standards Governing 

Certification of Local Vector 

Control Agency Personnel 167 

Article 1 . Definitions 167 

Article 2. Certification Examinafion 168 

Article 3. Condnuing Educafion 170 



CODE OF REGULATIONS Title 17 

Page 

Subchapter 3.1. Implementation of the 
Emergency Mosquito 
Abatement Funding Act of 
1983 170 

Article 1. General Provisions 170 

Article 2. Conditions Governing 
Expenditure of the 
Emergency Mosquito 
Abatement Trust Account or 
Fund 171 

Article 3. Criteria for Determining If 
a Local Agency Has 
Established Adequate 
Emergency Mosquito 
Abatement Procedures 171 

Subchapter 3.2. Importation of Wild 

Animals 171 

Article 1. General 171 

Arficle 2. Import Permits 171 

Article 3. Quarantine Facilities and 

Operating Standards 174 

Article 4. Quaranfine Provisions 174.1 

Article 5. Quarantine Records 174.2 

Article 6. Quaranfine Reporting 174.2 

Article 7. Cooperation with Other 

Governmental Agencies 174.2 

Article 8. Excepfions 174.2 

Subchapter 4. Radiation 175 

Group 1 . General 175 

Arficle 1 . Definifions 175 

Article 2. Exemptions and Enforcement .... 176 

Group 1.5. Registration of Sources of 

Radiation 176 

Article 1. Registration Procedure 176 

Article 2. Exclusions from 

Registrafion 177 

Article 3. Records 177 

Arficle 4. Fees 177 

Group 2. Licensing of Radioactive 

Materials 178 

Article 1. General 178 

Arficle 2. Definifions 179 

Article 3. Exemptions 179 

Article 4. Licenses 1 80 

Article 5. Transfer of Material 1 86 

Arficle 6. Enforcement 186 

Article 7. Reciprocal Recognition of 

Licenses 186 

Article 8. License Fees 186.1 



• 



Page vi 



(7-25-2008) 



Title 17 



Public Health 
Page 

Schedules 187 

Standards for Protection 

Against Radiation 191 

General 191 

Notices, Instructions, and 

Reports to Workers; 

Inspections and 

Investigations 192 

Surveys and Tests 195 

Records and Notification 196.1 

Special Requirements for the 
Use of X-Ray in the Healing 

Arts 197 

Requirements for the Use of 

X-Ray in Mammography 202.1 

Special Requirements for the 

Use of Radioactive Material 

in the Healing Arts 203 

Special Requirements for 
Radiographic Operations in 
Industrial Radiography 203 

Radiation Safety 

Requirements for Well 

Logging Operations 208.8 

Transportation of Radioactive 
Material 214 

Requirements for 
Transportation of 
Radioactive Material 214 

Participation by Local Health 
Departments 215 

Local Health Departments 215 

Radiologic Technology 233 

Administration 233 

Definitions 233 

Special Permits 233 

Requirements for Continuing 
Education Performance, and 
Renewal of Certificates and 
Permits 234 

Display of Certificates and 

Permits 234 

Deadlines 234 

Change of Name and Address 235 

Fees 235 

Authorization to X-Ray 

Technicians to Perform 

Digital Radiography 235 



Title Table of Contents 

Page 

Training of Students of 

Radiologic Technology 236 

General 236 

Radiologic Technology 

Schools 236 

Radiologic Technologist 
Fluoroscopy Permit Schools 237 

Limited Permit X-Ray 

Technician Schools 238 

On-the-Job Training for X- 

Ray Technicians 239 

Notification 239 

Disciplinary Action 239 

Additional School 
Requirements and 
Recordkeeping 240 

Certificates for Radiologic 
Technologists and Permits for 
Limited Permit X-Ray 
Technicians 240 

Certification of 

Technologists 240 

Permits for Limited Permit X- 

Ray Technicians 240 

Use of Fluoroscopy Equipment 

by Radiologic Technologists 240.1 

Radiologic Technologist 
Fluoroscopy Permits 240.1 

Use of Mammography Equipment 

by Radiologic Technologists 240.2 

Mammographic Technology 
Certificates 240.2 

Certification of Licentiates 240.2 

Licentiate Certificates and 

Permits 240.2 

Requirements for Land Disposal 

of Radioactive Waste 240.2(a) 

Applicable Federal 

Regulations 240.2(a) 

General 240.2(a) 

Proprietary Documents 240.2(a) 

Selection of License 

Designee 240.2(a) 

Forfeiture of Performance 

Bond 240.2(b) 

Fees 240.2(b) 

Financial Assurances 240.2(b) 

Rate Review and Approval 

Process 240.2(c) 



Article 9. 
Group 3. 

Article 1. 
Article 2. 



Article 3. 
Article 3.1. 
Article 4. 

Article 4.5. 
Article 5. 

Article 6. 

Article 7. 

Group 4. 
Article 1. 

Group 5. 

Article 1. 
Subchapter 4.5. 
Group 1. 
Article 1. 
Article 2. 
Article 3. 

Article 4. 

Article 5. 
Article 6. 
Article 7. 
Article 8. 



Group 2. 

Article 1. 
Article 2. 

Article 3. 

Article 4. 

Article 5. 

Article 6. 
Article 7. 
Article 8. 

Group 3. 

Article 1. 

Article 2. 
Group 4. 

Article 1. 
Group 4.5. 

Article 1. 

Group 5. 
Article 1. 

Group 7. 

Article 1. 

Article 2. 
Article 3. 
Article 4. 

Article 5. 

Article 6. 
Article 7. 
Article 8. 



Page vii 



Title Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Page 

Subchapter 4.6. Nuclear Medicine 

Technology 240.2(c) 

Article 1 . Definitions 240.2(c) 

Article 2. Certification of Nuclear 

Medicine Technologists 240.3 

Article 3. Administration 240.4 

Article 4. Exemptions and 

Enforcement 240.5 

Subchapter 5. Air Sanitation 241 

Article 1 . Standards for Ambient Air 

Quality 241 

Subchapter 6. Organized Camps 242 

Article 1 . General 242 

Article 2. Utilities 243 

Article 3. Housing 243 

Article 4. Food Service Facilities and 

Operations 244 

Article 4. 1 . Food Service Facilities and 
Operations at Intermittent 
Short-Term Organized Camps 
[Repealed] 244 

Article 5. Solid Waste 244 

Article 6. Vector Control 244 

Article 7. Swimming and Bathing 245 

Article 8. Supervision 245 

Subchapter 7. Wiping Rags 246 

Article 1 . Definitions 246 

Article 2. Minimum Standards for 

Sanitizing 246 

Subchapter 8. Drinking Utensils and Ice 

Buckets 246 

Article 1 . Definitions 246 

Article 2. Washing, Sanitizing, and 
Handling of Drinking 
Utensils and Ice Buckets in 
Hotels, Motels, and Other 
Public Places 246.1 

Chapter 6. Lead Poisoning Prevention 

Programs 247 

Article 1. Definitions 247 

Article 2. Fees 248.2 

Article 3. Exemption from Fees 248.3 

Article 4. Application to Reassess Fee 248.4 

Chapter 7. Health Facilities Planning 248.4 

Chapter 7.5. Eminent Domain Procedures for 

Nonprofit Hospitals 248.4 



Page 



Chapter 7.7. 


Fire Protection Loans 


. . . 248.4 


Chapter 8. 


Accreditation, Certification and 
Work Practices for Lead-Based 






Paint and Lead Hazards 


... ''48 4 


Article 1. 


Definitions 


... 248.4 


Article 2. 


Eligibility Requirements for 
Accreditation and Course 






Approval 


.. 248.14 


Article 3. 


Core Instruction 


.. ''48.16 


Article 4. 


Lead-Related Construction 
Inspection and Assessment 






Course 


.. 248.16 


Article 5. 


Lead-Related Construction 
Supervision and Project 






Monitoring Course 


.. 248.17 


Article 6. 


Lead-Related Construction 
Sampling Technician 






Course 


248.18(a) 


Article 7. 


Lead-Related Construction 






Work Course 


248.18(a) 


Article 8. 


Lead-Related Construction 
Supplemental Supervision 
and Project Monitoring 






Course 


248.18(b) 


Article 9. 


Lead-Related Construction 
Certified Industrial 






Hygienist Course 


248.18(c) 


Article 10 


Continuing Education 


248.18(d) 


Article 11. 


Application Requirements and 




Procedures for Training 






Provider Accreditation, 






Renewal, or Course 






Approval 


248.18(d) 


Article 12. 


Suspension or Revocation of 
Accreditation, Provisional 
Accreditation, or DHS 






Course Approval 


248.18(g) 


Article 13. 


Eligibility Requirements and 
Application Procedures for 
Certification or Interim 






Certification 


248.18(g) 


Article 14. 


Suspension or Revocation of 
Certification or Interim 






Certification 


248.18(k) 


Article 15. 


Enforcement 


.248.18(1) 


Article 16. 


Work Practice Standards 


.248.18(1) 


Chapter 9. 


Screening for Childhood Lead 






Poisoning 


. 248.18(n) 


Article 1 . 


Definitions 


. 248.18(n) 


Article 2. 


Standard of Care on 





Screening for Childhood 
Lead Poisoning 



248.18(0) 



Page viii 



(7-25- 



Title 17 



Public Health 

Page 

Occupational Lead Poisoning Article 1 . 

Prevention Program 248.1 8(0) Article 2 

Definitions 248.1 8(0) Article 3 

Waivers of the Occupational Subchapter 8. 

Lead Poisoning Fee 248.l8(p) 

Applicable Industries 248.19 

Health and Welfare Agency — 
Department of Developmental 
Services Regulations 249 Article 1 

General Provisions 249 Article 2. 

Monthly Parental Fee 249 

Article 3. 
General 249 

Definitions 249 

Administrative Provisions 250 Article 4. 

Determination of Ability to 

Pay 250 Subchapter 9. 

Determining Required Levels Article 1 . 

of Payment 251 

,5. Family Cost Article 2. 

Participation 252 Article 3. 

General 252 

Definitions 252 Article 4. 

Administrative Provisions 252.1 Article 5. 

Assessment of the Family Chapter 2. 

Cost Participation 252.1 Subchapter 1. 

Department of Article 1 

Developmental Services — . 

Conflict of Interest ^^^^*^ ^• 

Code 252.2 

T, 1 r /- J .■ Subchapter 2. 

Rules tor Conductmg ^ 

Research 252.3 

_^ ^. . . Article 1. 

Deimitions 252.3 

Article 2 
Rules for the Conduct of 

Research 253 Subchapter 3. 

Clients' Rights 257 

Article 1. 
Purpose and Definitions 257 

Article 2. 
Rights of Persons with 

Developmental Disabilities 258 

Article 3. 
Notification of Rights 259 

Denial of Rights 259 Subchapter 4. 

Complaint Procedure 261 

Clients' Rights Advocate 261 Article 1. 

Service Provider Article 2. 

Accountability 261 Subchapter 5. 

General Provisions 261 Article 1 . 

Fiscal Audit Appeals 267 Article 2. 



Title Table of Contents 

Page 

General 267 

Administrative Review 269 

Formal Hearing 270 

Peer Review of Behavior 

Modification 

Interventions That Cause 

Pain or Trauma, and 

Electroconvulsive 

Therapy 274 

General Provisions 274 

Review by Qualified 

Professional 275 

Review of Behavior 

Modification Treatment 

Plans 275 

Electroconvulsive Therapy 

(ECT) 276 

Fair Hearings 277 

General Provisions and 

Definitions 277 

Adequate Notice 278 

Procedures for Fair 

Hearings 278 

Miscellaneous Provisions 278 

Mediation 278.1 

Early Intervention Services 278.1 

General Provisions 278.1 

Definitions 278.1 

Eligibility for California's 

Early Start Program 278.3 

Program and Service 

Components 278.4 

Child Find & Referral 278.4 

Evaluation and Assessment 278.5 

Individualized Family 

Service Plan 278.6 

General 278.6 

Content and Procedures for 

thelFSP 278.6 

Transfer and Transition 

Procedures 278.9 

Service Coordination and 

Interagency Agreements 278.11 

Service Coordination 278.11 

Interagency Agreements 278.11 

Procedural Safeguards 278.12 

Notice and Consent 278.12 

Access Rights 278.13 



Chapter 1 1 . 

Article 1. 
Article 2. 

Article 3. 
Division 2. 



Chapter 1. 
Subchapter 2 
Article 1. 
Article 2. 
Article 3. 
Article 4. 

Article 5. 

Subchapter 2 

Article 1. 
Article 2. 
Article 3. 
Article 4. 

Subchapter 3 



Subchapter 4 

Article 1. 
Article 2. 

Subchapter 5 
Article 1. 
Article 2. 

Article 3. 
Article 4. 
Article 5. 
Article 6. 
Subchapter 6 

Article 1. 
Subchapter 7 



Page ix 



Title Table of Contents BARCLAYS CALIFORNIA 

Page 

Articles. Complaint Process 278.14 

Article 4. Mediation and Due Process 

Procedures 278.16 

Articles. Surrogate Parents 278.17 

Chapter 3. Community Services 278.17 

Subchapter 1. General 278.17 

Article 1 . Definitions 278.17 

Article 2. Eligibility 278.18 

Subchapter 2. Vendorization 278.18 

Article 1. Definitions 278.18 

Article 2. Vendorization Process 279 

Article 3. Vendor Numbers and Service 

Codes 282.9 

Article 4. Vendor Compliance and 

Prohibitions 282.20 

Article 5. Vendorization Appeal 282.21 

Subchapter 3. Regional Center 

Administrative Practices 

and Procedures 282.23 

Article 1 . Regional Center Conflict of 
Interest Standards and 
Procedures 282.23 

Subchapter 3.5. Regional Center Budget 

Deficit Controls 282.26 

Article 1. Definitions 282.26 

Article 2. Service Authorization and 

Review 282.26 

Article 3. Plans of Action 282.27 

Article 4. Service Standards 283 

Subchapter 4. Residential Services and 
Quality Assurance 
Regulations 284 

Article 1 . Definitions 284 

Article 2. General Requirements 286 

Article 3. Program Design 288 

Article 4. Consumer Placement and 

Relocation 289 

Article 5. Consumer Services 291 

Article 6. Welfare and Institutions 

Code Section 4695.2 Direct 

Care Staff Training 

Regulations 292 

Article 7. Personnel 292.3 

Article 8. Monitoring and Evaluation 292.5 

Article 9. Corrective Action Plans and 

Sanctions 292.8 

Article 10. Records Maintenance 292.8(b) 



CODE OF REGULATIONS Title 17 

Page 

Article 11. Facility Appeals Process . . . 292.8(b)(2) 

Subchapter 4. 1 . Family Home Agency (FHA) 

Regulations 292.8(b)(3) 

Article 1. Definitions 292.8(b)(3) 

Article 2. Competitive 

Procurement 292.8(b)(4) 

Article 3. Contract and 

Vendorization 292.8(d) 

Article 4. Program Design 292.8(d) 

Article 5. Criminal Record 

Clearance 292.8(e) 

Article 6. The FHA 292.8(f) 

Article 7. The Family Home 292.8(g) 

Article 8. Referral for Service 292.8(h) 

Article 9. Consumer Funds and 

Property 292.8(h) 

Article 10. Health-Related Services 292.8(i) 

Article 11. Abuse and Special Incident 

Reporting 292.8(i) 

Article 12. Termination of Residency 292.8(j) 

Article 13. Monitoring and Sanctions 292. 8(j) 

Article 14. Appeals 292.8(k) 

Subchapter 4.2. Intermediate Care 
Facility (ICF); 
Intermediate Care 
Facility/Developmentally 
Disabled (ICF/DD); 
Intermediate Care 
Facility/Developmentally 
Disabled-Habilitative 
(ICF/DD-H); Intermediate 
Care Facility/ 

Developmentally Disabled- 
Nursing (ICF/DD-N); 
Skilled Nursing Facility 
(SNF) Monitoring 
Requirements 292.8(n) 

Article 1 . Definitions 292.8(n) 

Article 2. Monitoring 292.8(n) 

Subchapter 5. Standards for 

Nonresidential Services 292.8(o) 

Article 1. Definitions 292.8(o) 

Article 2. Standards for All Community- 
Based Day Programs 292. 8(p) 

Article 3. Additional Standards for 

Adult Day Programs 292.13 

Article 4. Additional Standards for 
Infant Development 
Programs 292.16 

Article 5. Standards for In-Home 

Respite Services Agencies 292.18 



Page X 



(7-25-20 



Title 17 



Public Health 

Page 

Ratesetting Procedures 

for Residential 

Services 292.22(a) 

Definitions 292.22(a) 

General Provisions 292.23 

Cost Studies 292.24 

Rates Development 

Methodology 292.26 

Rate Proposals 292.28 

Reimbursement Policies 292.29 

Verification of Use of Rate 

Increase Funds 292.30 

Nonresidential Service 

Vendor Rate-Setting 

Provisions 292.33 

Definitions 292.33 

General Provisions 292.34 

Vouchers 292.35 

Rates of Reimbursement Based 

on the Schedule of Maximum 

Allowances or the Vendor's 

Usual and Customary Rate 292.35 

Rate-Setting Procedures 

for Community-Based Day 

Programs 292.36(b) 

(Reserved) 292.36(b) 

General Provisions 292.36(b) 

Submission of Required 

Information 292.36(b) 

Review Requirements 292.37 

Rate-Setting Methodology 
for Community-Based Day 
Programs 292.39 

Permanent Payment Rates 292.39 

Temporary Payment Rate 292.42 

Non-Mobile Supplemental 

Rate 292.42 

Service Contracts 292.43 

Schedule of Payment Rates 
for Community-Based Day 
Programs 292.44 

General Provisions 292.44 

Schedule of Payment Rates 
forFiscal Year 1990-91 292.44 

Schedule of Payment Rates 

for Fiscal Year 1991-92 292.44 



Title Table of Contents 

Page 

Schedule of Payment Rates 
for Fiscal Year 1996-97 and 
Each Alternate Fiscal Year 
Thereafter 292.45 

Schedule of Payment Rates 
for Fiscal Year 1997-98 and 
Each Alternate Fiscal Year 
Thereafter 292.45 

Timelines for Rate 
Establishment and Written 
Notification 292.46 

Reporting Requirements 

for Community-Based Day 

Programs 292.47 

Annual Report to the 

Legislature 292.47 

Calculation of the Statewide 

Fiscal Impact of the Gap 292.47 

Rate Adjustments, Audit 
Adjustments and Rate 
Appeals for Community- 
Based Day Programs 292.47 

General Provisions 292.47 

Rate Adjustments 292.49 

Audit Adjustments 292.50 

Rate Appeals 292.50 

Rate-Setting Procedures 

for In-Home Respite 

Services Agency Vendors 292.62 

Definitions 292.62 

General Provisions 292.62 

Submission of Required 
Information 292.63 

Review Requirements 292.66 

Rate-Setting Methodology 

for In-Home Respite 

Services Agency Vendors 292.67 

Permanent Payment Rates 292.67 

Temporary Payment Rate 292.69 

Supplemental Rate for 
Respite Worker Travel 

Costs 292.69 

Negotiating the Level of 

Payment When Serving More 

than One Consumer 292.70 

Payment Rates for Existing 

In-Home Respite Services 

Agency Vendors 292.70 

Schedule of Payment Rates 

for In-Home Respite 

Services Agency Vendors 292.70 



Subchapter 6. 

Article 1. 
Article 2. 
Article 3. 
Article 4. 

Article 5. 
Article 6. 
Article 7. 

Subchapter 7. 

Article 1. 
Article 2. 
Article 3. 
Article 5. 



Subchapter 8. 

Article 1. 
Article 2. 
Article 3. 

Article 4. 
Subchapter 9. 

Article 1. 
Article 2. 
Article 3. 

Article 4. 
Subchapter 10. 

Article 1. 
Article 2. 

Article 3. 



Article 4. 

Article 5. 

Article 6. 

Subchapter 11. 

Article 1. 
Article 2. 
Subchapter 12. 



Article 1. 
Article 2. 
Article 3. 
Article 4. 
Subchapter 13. 

Article 1. 
Article 2. 
Article 3. 

Article 4. 
Subchapter 14. 

Article 1. 
Article 2. 
Article 3. 

Article 4. 

Article 5. 

Subchapter 15. 



Page xi 



Title Table of Contents BARCLAYS CALIFORNIA 

Page 

Article 1. General Provisions 292.70 

Article 2. Schedule of Payment Rates 

for Fiscal Year 1990-91 292.71 

Article 3. Schedule of Payment Rates 

for Fiscal Year 1991-92 292.71 

Article 4. Schedule of Payment Rates 
for Fiscal Year 1 996-97 and 
Each Alternate Fiscal Year 
Thereafter 292.71 

Article 5. Schedule of Payment Rates 
for Fiscal Year 1997-98 and 
Each Alternate Fiscal Year 
Thereafter 292.72 

Article 6. Timelines for Rate 

Establishment and Written 
Notification 292.73 

Subchapter 16. Reporting Requirements 
for In-Home Respite 
Services Agency Vendors 292.73 

Article 1 . Annual Report to the 

Legislature 292.73 

Article 2. Calculation of the Statewide 

Fiscal Impact of the Gap 292.74 

Subchapter 17. Rate Adjustments, Audit 
Adjustments and Rate 
Appeals for In-Home 
Respite Services Agency 
Vendors 292.74 

Article 1 . General Provisions 292.74 

Article 2. Rate Adjustments 292.74 

Article 3. Audit Adjustments 292.74(b) 

Article 4. Rate Appeals 292.74(b) 

Subchapter 18. Transportation Service 292.74(h)(6) 

Article 1. Definitions 292.74(h)(6) 

Article 2. General Provisions 292.74(h)(6) 

Article 3. Standards for Transportation 

Service Vendors 292.74(h)(7) 

Article 4. Competitive 

Procurement 292.74(h)(9) 

Article 5. Noncompetitive 

Procurement 292.74(h)(l0) 

Article 6. Noncompetitive Procurement 
Based on Cost 
Statement 292.74(h)(ii) 

Article 7. Appeals 292.74(h)(13) 

Article 8. Transitory Provisions 292.74(h)(i5) 

Subchapter 19. Supported Living Service 292.74(m) 

Article 1 . Definitions 292.74(m) 

Article 2. General Provisions 292.74(n) 



CODE OF REGULATIONS Title 17 

Page 

Article 3. Consumer Rights 292.76 

Article 4. Service Design 292.77 

Article 5. Standards for Vendors 292.78 

Article 6. Training Requirements 292.79 

Article 7. Rate Negotiation 292.80 

Article 8. SLS Contract Standards 292.81 

Article 9. Performance Evaluations 292.82 

Subchapter 2 1 . Habilitation Services 

Program 292.82 

Article 1. Definitions 292.82 

Article 2. General Requirements for All 

Habilitation Services 292.85 

Article 3. Standards for Work Activity 

Programs 292.86 

Article 4. Standards for Supported 

Employment Programs 292.88 

Article 5. Coordination of Services 
With the Department of 
Rehabilitation 292.90 

Article 6. Quality Assurance Monitoring 
and Corrective Actions for 
Habilitation Services 
Programs 292.91 

Article 7. Work Activity Program 

Ratesetting Procedures 292.92 

Article 8. Ratesetting Methodology for 

Work Activity Programs 292.94 

Article 9. Billing and Payment 292.98 

Chapter 4. Case Management 292.99 

Subchapter 1 . General 292.99 

Article 1. Definitions 292.99 

Article 2. Case Management 

Services 292.100 

Article 3. Assessment Procedures 292.100 

Article 4. Billings and Collections 292.100 

Division 3. Air Resources 293 

Chapter 1 . Air Resources Board 293 

Subchapter 1. Administrative 

Procedures 293 

Article 1. Board Meetings and Hearings 293 

Article 2. State Board Review of 

Executive Officer Actions 294 

Article 3. Permit Procedures 294 

Subchapter 1.25. Administrative Procedures — 

Hearings 295 

Article 1. Adjudicatory Hearings 295 

Article 2. Administrative Hearing 
Procedures for Petitions 
for Review of Executive 
Officer Decisions 297 



Page xii 



(7-25-2008) 



Title 17 



Public Health 

Page 

General Provisions 297 Subarticle 

Hearing Officers 298.2 Subarticle 

Ex Parte Communications 298.2 Subarticle 

Filing and Initial Review 

of Petitions for Review Subarticle 

and Executive Officer's Subarticle 

Response 298.3 

Prehearing Procedures 298.4 Article 4 

Contempt and Sanctions 298.8 

Hearings 298.9 

„ . . r.i TT • Subarticle 

Decisions oi the Hearing 

Officer 298.10 Subarticle 

Reconsideration 298.1 1 

Final Order or Decision; 

Judicial Review 298.1 1 Subarticle 

Administrative Procedures Subarticle 

for Review of Executive 

Officer Determinations Subarticle 

Regarding Service 

Information for 1 994 and c u .• i 

A * . , xr Subarticle 

Subsequent Model Year 

Passenger Cars, Light-Duty 

Trucks, and Medium-Duty 

Engines and Vehicles and Subarticle 

2007 and Subsequent Model 

Year Heavy-Duty Engines 298.12 Subarticle 

General Provisions 298.12 Subarticle 

Hearing Officers 298.12(b) Subarticle 

Ex Parte 

Communications 298.12(c) Subarticle 

Filing Requests for 

Administrative Hearing Subarticle 

Review 298.12(c) Article 6. 

Pre-Hearing Procedures . . . 298.12(e) 
Contempt and Sanctions . . . 298.12(1) 

Review Proceedings 298.12(g) ^ , , 

Subchapter 1.5. 

Decisions of the Hearing 

Officer 298.12(h) . ., , 

Article 1. 

Judicial Review 298.i2(i) 

Administrative Hearing Article 1.5. 

Procedures for Review of * • , ^ 

„ , . Article 2. 

Complaints 298.12(1) 

General Provisions 298.12(1) * _.• i -, 

Article 3. 

Hearing Officers 298.13 

Ex Parte Communications . . . 298.14 Article 5. 

Issuance of and Response Article 6. 

to Complaints 298.15 Article 1 

Prehearing Procedures 298.16 



Title Table of Contents 
Page 

6. Contempt and Sanctions 298.20 

7. Hearings 298.21 

8. Decisions of the Hearing 

Officer 298.22 

9. Reconsideration 298.23 

10. Final Order or Decision; 

Judicial Review 298.24 

Administrative Hearing 

Procedures for Review of 

Citations 298.24 

1. General Provisions 298.24 

2. Issuance and Service of 
Citations 298.27 

3. Hearing Officers 298.28 

4. Ex Parte Communication 298.28 

5. Initiating Proceeding to 

Contest a Citation 298.29 

6. Resolution of Proceeding 
Without Hearing 298.30 

7. Discovery, and Subpoenas 
and Subpoenas Duces 

Tecum 298.31 

8. Contempt and Sanction 

Orders 298.33 

9. Hearings 298.33 

10. Decisions After Hearing 298.36 

1 1 . Reconsideration by the 
Executive Officer 298.37 

12. Final Orders or 

Decisions 298.38 

13. Judicial Review 298.38 

Definition of Minor 

Violation and Guidelines 

for Issuance of Notice to 

Comply 298.38 

Air Basins and Air 

Quality Standards 298.40 

Description of California 

Air Basins 298.40 

Area Pollutant Designations 300 

Ambient Air Quality 

Standards 304 

Criteria for Determining 

Area Designations 308 

Transported Air Pollutants 312.1 

Transport Mitigation 312.2 

Emission Accounting 

Procedure 312.3 



Subarticle 1. 
Subarticle 2. 
Subarticle 3. 
Subarticle 4. 



Subarticle 5. 
Subarticle 6. 
Subarticle 7. 
Subarticle 8. 

Subarticle 9. 
Subarticle 10. 



Article 2.5. 



Subarticle 1. 
Subarticle 2. 
Subarticle 3. 

Subarticle 4. 

Subarticle 5. 
Subarticle 6. 
Subarticle 7. 
Subarticle 8. 

Subarticle 9. 
Article 3. 

Subarticle 1. 
Subarticle 2. 
Subarticle 3. 
Subarticle 4. 

Subarticle 5. 



Page xiii 



(7 2S 2()0S) 



Title Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Subchapter 1.6. 
Subchapter 2. 

Article 1. 
Article 2. 

Article 3. 
Subchapter 2.5. 

Subchapter 2.6. 

Subchapter 2.7. 

Subchapter 3. 
Article 1 . 
Article 2. 
Article 3. 

Article 4. 
Subchapter 3.5. 

Article 1. 



Article 2. 



Article 3. 



Page 

Local Air Pollution 

Control District 

Regulations 312.4 

Smoke Management 

Guidelines for 

Agricultural and 

Prescribed Burning 312.5 

General Provisions 312.5 

District Smoke Management 
Program 314 



Page 



Meteorological Criteria for 
Regulating Agricultural and 
Prescribed Burning 317 



Compliance Schedule 

Regarding Visible 

Emissions from Specified 

Vessels 321 

Air Pollution Control 

District Rules 321 

Large Confined Animal 

Facilities 322 



Subventions 



General Provisions 



Application Procedures 



Application Processing, 
Disbursements, and Reports 

Appeals 



, . 322 
, . 322 
322.1 

322.2 
, . 323 



Acid Deposition Fee 
Program 



Fee Program to Be 
Implemented by Air 
Pollution Control Districts 
and Air Quality Management 
Districts for Fiscal Year 
1983-1984 



323 



323 



Fee Program to Be 
Implemented by Air 
Pollution Control Districts 
and Air Quality Management 
Districts for Fiscal Year 
1984-1985 



323 



Fee Program to Be 
Implemented by Air 
Pollution Control Districts 
and Air Quality Management 
Districts for Fiscal Year 
1985-1986 



Article 4. 



Article 5. 



Article 6. 



Subchapter 3.6. 

Article 1. 

Article 2. 

Article 3. 

Subchapter 3.8. 



Subchapter 4. 

Article 1. 
Article 2. 

Article 3. 

Subchapter 5. 

Article 1. 

Article 2. 
Subchapter 5.5. 

Article 1. 
Subchapter 5.6. 

Article 1. 

Article 2. 
Article 3. 



Fee Program to Be 
Implemented by Air 
Pollution Control Districts 
and Air Quality Management 
Districts for Fiscal Year 
1986-1987 



324 



Fee Program to Be 
Implemented by Air 
Pollution Control Districts 
and Air Quality Management 
Districts for Fiscal Year 
1987-88 



324 



Fee Requirements to Be 
Implemented by Air 
Pollution Control Districts 
and Air Quality Management 
Districts for the 
Atmospheric Acidity 
Protection Act Program 



Air Toxics "Hot Spots" 
Fee Regulation 



General 



325 

325 
325 



Applicability 327 

Fees 328 

Nonvehicular Source, 

Consumer Products, and 

Architectural Coatings 

Fee Regulations 333 

Disclosure of Public 

Records 337 

General 337 

Board's Requests for 

Information 337 

Inspection of Public 

Records 337 

Emission Data, Sampling, 

and Credentials for 

Entry 338 

Determination of Emissions 338 

Source Testing 338 

341 



Interchangeable Air 
Pollution Emission 
Reduction Credits . . 



Scope and Policy; 
Definitions 



341 



341 



341 



324 



Credit Exchange Function 342 

Criteria and Methodology for 
Generation and Use of 
Interchangeable Credits 342 



Page xiv 



(7-25-2008) 



Title 17 



Public 
Page 

Abrasive Blasting 344 

General Provisions 344 

Prohibitions 344 

Source Evaluation 345 

Performance Standards 345 

Toxic Air Contaminants 346 

Airborne Toxic Control 

Measures 348 

Emission Inventory 

Criteria and Guidelines 358.44 

General 358.44 

Applicability 358.45 

Requirements for Preparing 
Emission Inventory Plans 358.45 

Requirements for Emission 
Inventory Reports 358.46 

Other Requirements 359 

Updates 360 

Compliance with 

Nonvehicular Emission 

Standards 361 

Vapor Recovery Systems in 

Gasoline Marketing 

Operations 361 

Test Methods for Determining 
Compliance with District 
Nonvehicular Emission 
Standards 364 

Distributed Generation 

Certification Program 368.3 

Consumer Products 368.6 



Health 



Title Table of Contents 

Page 

Antiperspirants and 

Deodorants 368.6 

Consumer Products 373 

Aerosol Coating Products 395 

Alternative Control Plan 396.8 

Hairspray Credit Program 404 

6. Maximum Incremental 

Reactivity 41 ] 

Tables of Maximum 

Incremental Reactivity 

(MIR) Values 411 

Conflict of Interest 

Code 417 

General Provisions 417 

Appendix: Designated 
Employees and Disclosure 
Categories 417 

Office of Environmental Health 
Hazard Assessment 419 

Pesticide Program 419 

Pesticide-Related Illness 

and Injury 419 

Reporting 419 

California Institute for 

Regenerative Medicine 421 

Human Embryonic Stem Cell 

Research 423 

Intellectual Property and 

Revenue Sharing Requirements 

for For-Profit Organizations 431 



Subchapter 6. 

Article 1. 

Article 2. 

Article 3. 

Article 4. 
Subchapter 7. 
Subchapter 7.5. 

Subchapter 7.6. 

Article 1. 
Article 2. 
Article 3. 

Article 4. 

Article 5. 

Article 6. 

Subchapter 8. 

Article 1. 

Article 2. 



Article 3. 
Subchapter 8.5. 



Article 1. 

Article 2. 
Article 3. 
Article 4. 
Article 5. 
Subchapter 8 

Article 1. 

Subchapter 9 

Article 1. 
Article 2. 

Division 3.5. 

Chapter 2. 
Subchapter 1 

Article 1. 
Division 4. 

Chapter 2. 

Chapter 4. 



Page XV 



Barclays Official 

California 

Code of 
Regulations 



Title 17. Public Health 

Division 1. State Department of Health Services 



Vol. 22 



XMOIVISOIM 

^ 

^A/EST 



Barclays Official California Code of Regulations 

425 Market Street • Fourth Floor • San Francisco, CA 94105 
800-888-3600 



Title 17 



State Department of Health Services 



Table of Contents 



Division 1. State Department of Health Services 



Table of Contents 



Chapter 1 . 
Subchapter 1 . 

Subchapter 2. 

Article 1 . 
§ 100. 
§ 101. 
§ 102. 
§ 103. 

Subchapter 3. 
Group 1. 
Group 2. 
Subgroup 2. 

Group 3. 
Group 4. 



Group 5. 
Subchapter 4. 
Article 1. 



§901. 

ij902. 
§903. 

Article 2. 

§908. 

Article 3. 

§910. 
§911. 

§912. 

Article 4. 

§915. 
§916. 

Subchapters. 



Page 

Administration l 

State Department of 

Health Services i 

Hospital Districts l 

Liability Loans i 

Eligibility Requirements. 
Loan Application. 
Coverage. 
Repayment of Loans. 

Hospital Inspection i 

Clinics and Dispensaries 2 

Health Facilities 2 

Requirements for Outpatient 

Clinics 2 

Nonprofit Hospitals 2 

Establishments for Handicapped 
Persons 2 

Public Medical Institutions 2 

Records and Statistics 2 

Access to the Records in the 

Office of the State 

Registrar and in the 

Offices of Local 

Registrars 2 

Access to the Records in the Office 

of the State Registrar and in the 

Offices of Local Registrars. 

Conditions of Examination. 

Fee for Examination or Search. 

Late Registration of Births 

and Deaths 3 

Late Registration of Births and 

Deaths. 

Birth Certificates of 

Deceased Persons 3 

Responsibilities of Local Registrar 

or County Recorder. 

Identification of Deceased 

Registrants by Local Registrars and 

County Recorders. 

Certified Copies of Birth 

Certificates of Deceased Persons. 

Definitions of Live Birth 

and Fetal Death 3 

Live Birth. 
Fetal Death. 

Home Health Agency 

Licensing Requirements 4 



Page 

Chapter 2. Laboratories 4 

Subchapter 1 . Service Laboratories 4 

Group 1. Production and Distribution of 

Biologies 4 

Article 1 . Licenses 4 

§ 950. General Provisions. 

§ 951 . Issuance of License. 

§ 952. Application for Renewal of License. 

§953. License Fees. 

Article 2. Exemptions 4 

§ 956. Autogenous Vaccines. 

Article 3. Inspection and Records 4 

§ 962. Inspection by Department. 

§ 963. Records. 

Article 4. Storage 5 

§ 967. Storage. 

Article 5. Containers and Labeling 5 

§ 972. Containers and Labeling. 

Article 6. Advertising 5 

§ 977. Advertising. 

Article 7. Samples 5 

§ 982. Potency. 

Article 8. Vaccine Culture 5 

§ 987. Vaccine Culture. 

Article 9. Preparation and Distribution 

of Whole Blood (Human) 5 

§ 997. Definitions. 

§ 998. Personnel of Blood Banks and Their 

Auxiliaries. 
§ 999. Blood Bank Equipment. Facilities 

and Manual. 
§ 1000. Blood Bank Records; Identification 

of Human Blood with Its Donor. 
§ 1001. Labels. 

§ 1002. Requirements — Donors, Medical 

History, Blood Collection, Storage 

and Testing. 
§ 1002.1. Use of AIDS Antibody (HTLV-III) 

Test by Blood Banks. 
§1003. Excepfions for Emergency 

Purposes. 
§ 1004. Reporting Requirements. 

Article 10. Preparation and Distribution 

of Normal Human Plasma 8 

§ 1010. Procurement of Blood for Plasma 

Processing. 
§1011. Personnel and Equipment. 

§ 1012. Single Donor Plasma and Single 

Donor Fresh Frozen Plasma 

(Antihemophilic). 
§ 1013. Storage. 

§1014. Expiration Date. 

§1015. Other Tests. 

§ 1016. Filling the Final Container 

§ 1017. Labeling. 



Page 



(7 :'i 2(1(1S| 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Page 



Page 



§ 1018. 


Diluent for Dried Plasma. 


§ 1021. 


Rcquiiements for Release. 


Article 11. 


Preparation of Other Blood 




Derivatives 8 


§ 1024. 


Red Blood Cells (Human). 


§ 1024.1. 


Frozen Red Blood Cells. 


§ 1025. 


Plasmapheresis. 


§ 1026. 


Other Blood Fractions; Procedures; 




Standards; Consultative Service. 


Article 12. 


Transportation of Etiologic 




Agents 9 


§ 1027. 


Definitions and Procedures to Be 




Followed. 


Article 13. 


Research Projects 9 


§ 1028. 


Waiver of Regulations. 


Group 2. 


Clinical Laboratory 




Regulations 9 


Article 1. 


Definitions 9 


§ 1029. 


General Definitions. 


§ 1029.5. 


Accreditation Body. 


§ 1029.6. 


Accredited Institution. 


§ 1029.7. 


Accredited College or University. 


§ 1029.9. 


Accredited Institution. 


§ 1029.10. 


Accusation. 


§ 1029.11. 


Antigen. 


§ 1029.13. 


Approved Public Health Laboratory. 


§ 1029.15. 


Alternative Sanction. 


§ 1029.17. 


CLIA Certificate. 


§ 1029.19. 


CLIA Exempt Status. 


§ 1029.20. 


Antibody. 


§ 1029.23. 


Direct Patient Care. 


§ 1029.25. 


Antigen. 


§ 1029.27. 


HHS. 


§ 1029.30. 


Approved Public Health Laboratory. 


§ 1029.31. 


Arterial Puncture. 


§ 1029.32. 


Certified Phlebotomy Technician I. 


§ 1029.33. 


Certified Phlebotomy Technician II. 


§ 1029.34. 


Certifying Organization. 


§ 1029.35. 


Chapter 3. 


§ 1029.37. 


Instrument. 


§ 1029.39. 


Licensed General Acute Care 




Hospital. 


§ 1029.40. 


Civil Money Penalties. 


§ 1029.43. 


Patient. 


§ 1029.44. 


Preceptor. 


§ 1029.45. 


CLIA Certificate. 


§ 1029.47. 


Respiratory Care Practitioner. 


§ 1029.49. 


Specimen. 


§ 1029.50. 


CLIA Exempt Status. 


§ 1029.51. 


Clinical Consultant. 


§ 1029.52. 


Clinical Cytogenetics. 


§ 1029.53. 


Clinical Genetic Molecular Biology. 


§ 1029.55. 


Condition Level Deficiency. 


§ 1029.57. 


Test Purposes. 


§ 1029.59. 


Unprofessional Conduct. 


§ 1029.60. 


Condiuon Level Requirement. 


§ 1029.65. 


Deficiency. 


§ 1029.70. 


Direct Patient Care. 


§ 1029.75. 


Directed Plans of Correction. 


§ 1029.80. 


Electrolytes. 


§ 1029.81. 


Evidence of Satisfactory 




Performance. 


§ 1029.82. 


Field Related to Genetics. 


§ 1029.83. 


General Supervisor. 


§ 1029.85. 


HHS. 


§ 1029.86. 


High Complexity Tests or 




Examinations. 


§ 1029.90. 


Human Immunodeficiency Virus. 


§ 1029.95. 


Immediate Jeopardy. 


§ 1029.100. 


Instrument. 


§ 1029.105. 


Intermediate Sanction. 


§ 1029.108. 


License. 



§ 1029.110. 


Licensed General Acute Care 




Hospital. 


§ 1029.111. 


Licensed Healthcare Professional. 


§ 1029.115. 


Licensed Surgical Clinic. 


5$ 1029.116. 


Limited Phlebotomy Technician. 


§ 1029.117. 


Medical Laboratory Technician. 


§ 1029.118. 


Moderate Complexity Laboratory 




Technical Consultant. 


§ 1029.119. 


Moderate Complexity Tests or 




Examinations. 


§ 1029.120. 


Notice of Defense. 


§ 1029.124. 


On-the-job Experience in 




Phlebotomy. 


§ 1029.125. 


Onsite Monitoring. 


§ 1029.126. 


Oral and Maxillofacial Pathology 




Laboratoi7 Director. 


§ 1029.127. 


Oral Pathology. 


§ 1029.130. 


Patient. 


§ 1029.132. 


Phlebotomist. 


§ 1029.133. 


Phlebotomy. 


§ 1029.134. 


Practical Experience. 


§ 1029.135. 


Preceptor. 


§ 1029.140. 


Principal Sanction. 


§ 1029.145. 


Provider of Service. 


§ 1029.150. 


Respiratory Care Practitioner. 


§ 1029.153. 


Satisfactory Performance. 


§ 1029.154. 


Skin Puncture. 


§ 1029.155. 


Specimen. 


§ 1029.160. 


State License. 


§ 1029.165. 


State Registration. 


§ 1029.168. 


Statement of Issues. 


§ 1029.169. 


Subspecialty of Histocompatibility. 


§ 1029.170. 


Temporary Suspension of a License, 




Registration or Approval. 


§ 1029.171. 


Technical Supervisor. 


§ 1029.173. 


Temporary Suspension of a License, 




Registration or Approval. 


§ 1029.175. 


Temporary Suspension of a Provider 




of Service Under the Medi-Cal 




Program. 


§ 1029.180. 


Test Purposes. 


§ 1029.185. 


TesUng Event. 


§ 1029.190. 


Unprofessional Conduct. 


§ 1029.195. 


Venipuncture. 


§ 1029.196. 


Waived Laboratory Supervisor. 


§ 1029.197. 


Waived Tests. 


icle 1.5. 


Licensure of Clinical 




Laboratory Personnel 19 


§ 1030. 


Examination for Bioanalysts' 




Licenses. 


§ 1030.5. 


Licensure of Chnical Chemists, 




Clinical Microbiologists, Clinical 




Toxicologists, Clinical Genetic 




Molecular Biologists and Clinical 




Cytogeneticists. 


§ 1030.6. 


Licensure of Clinical 




Cytogeneticists. 


§ 1030.7. 


Licensure of Clinical Genetic 




Molecular Biologists. 


§ 1030.8. 


Licensure of Oral Pathology 




Laboratory Directors. 


§ 1031. 


Licensure of Clinical Laboratory 




Specialists. 


§ 1031.1. 


Licensure of Clinical 




Histocompatibility Scientists. 


§ 1031.2. 


Licensure of Clinical Cytogeneticist 




Scienfists. 


§ 1031.3. 


Licensure of Clinical Genetic 




Molecular Biologist Scienfists. 


§ 1031.4. 


Requirements and Timeframes for 




ApplicaUons for Licensure and 




Certificafion. 


§ 1031.5. 


Requirements and Timeframes for 




Renewal of Licenses and 




Certificates. 



Page 



(7-25-2008) 



Title 17 



State Department of Health Services 



Table of Contents 



Page 



Page 



§ 1031.7. 



§ 1031.8. 



§ 1031.9. 



• 



§ 1032. 


Examination for Clinical Laboratory 




Technologist's License. 


§ 1032.5, 


Licensure of Medical Laboratory 




Technicians. 


§ 1033. 


Trainee Requirements. 


§ 1034. 


Certification of Phlebotomy 




Technicians. 


§ 1034.1. 


Unlicensed Personnel. Laboratory 




Aides. 


§ 1034.2. 


Unlicensed Personnel, 




Cytotechnologist. 


Article 2. 


Training 20.10 


§ 1035. 


Training Schools. 


§ 1035.1. 


Phlebotomy Training Program 




Requirements. 


§ 1035.3. 


Medical Laboratory Technician 




Training Program Standards. 


§ 1035.4. 


Timeframes for Approval of 




Training Programs. 


Article 2.3. 


Clinical Laboratory 




Supervisors 20.13 


§ 1036. 


Chnical Consultant. 


§ 1036.1. 


General Supervisor. 


§ 1036.2. 


Moderate Complexity Laboratory 




Technical Consultant. 


§ 1036.3. 


Waived Laboratory Supervisor. 


§ 1036.4. 


Technical Supervisor. 


Article 2.5. 


Continuing Education 20.15 


§ 1038. 


Definitions. 


§ 1038.1. 


Continuing Education 




Requirements. 


§ 1038.2. 


Accrediting Agencies. 


§ 1038.3. 


Approval of Providers. 


§ 1038.4. 


Approved Providers. 


§ 1038.5. 


Waiver of Requirement. 


§ 1038.6. 


Inactive Status. 


§ 1038.7. 


Fees. 


Article 2.8. 


CLIA Certification/State 




Licensure 22 


§ 1039.1. 


Recognition of CLIA Certification 




for Limited Purpose and Period. 


§ 1039.2. 


Clinical Laboratory Personnel 




Requirements. 


§ 1039.3. 


State Licensure or Approval 




Required During CLIA Exemption. 


Article 3. 


License 22 


§ 1040. 


Forfeited Licenses. 


§ 1041. 


Fee Credits. 


§ 1042. 


Substantial Relationship Criteria. 


§ 1042.1. 


Criteria for Evaluating 




Rehabilitation. 


Article 4. 


Personnel Report 22.1 


§ 1045. 


Personnel Report. 


Article 5. 


Issuance of License 22.1 


§ 1050. 


Clinical Laboratory Standards. 


§ 1051. 


Proficiency Testing Services. 


§ 1052. 


Satisfactory Performance in 



§ 1053.5, 


Article 5.3. 


§ 1054.1. 
§ 1054.2. 


Article 5.5. 


§ 1054.5. 


Article 5.6. 



§ 1054.6. 



§ 1054.7. 



Proficiency Testing. 



Article 6. 

§ 1055. 
§ 1056. 

§ 1057. 

Article 7. 

§ 1060. 

§ 1061. 
§ 1062. 

Article 8. 

§ 1065. 
§ 1065.5. 
§ 1065.10. 
§ 1065.15. 
§ 1065.20. 
§ 1065.25. 

§ 1065.30. 

§ 1065.35. 
§ 1065.40. 

§ 1065.45. 



22.3 



22.4 



22.4 



Definitions. 
Test Kits Approved for Over- 
the-Counter Sale to the 
Public by the United States 
Food and Drug 
Administration 

HIV Tests. 

Blood Electrolyte Analysis 
by Respiratory Care 
Practitioners 

Conditions for Performance. 

Training. 

Use of Point-of-Care 
Laboratory Testing Devices 

by Registered Nurses 

Conditions for Performance. 

Moderately Complex 

Laboratory Testing by 

Licensed Psychiatric 

Technicians, Licensed 

Vocational Nurses, Licensed 

Midwives, Certified Nurse 

Assistants, and Certified 

Home Health Aides 22.4(a) 

Tesdng Authority for Licensed 

Psychiatric Technicians, Licensed 

Vocational Nurses, Licensed 

Midwives, Certified Nurse 

Assistants, and Certified Home 

Health Aides. 

Preceptor Program Requirements for 

Licensed Psychiatric Technicians, 

Licensed Vocational Nurses, 

Licensed Midwives, Certified 

Elmergency Medical Technicians II, 

Paramedics, Certified Nurse 

Assistants, and Certified Home 

Health Aides Performing Moderate 

Complexity TesUng on 

Point-of-Care Laboratory Testing 

Devices. 

Laboratory Reports 22.4(a) 

Reports. 

Prenatal and Neonatal Blood 

Typing. 

Prenatal Blood Typing Reports. 

Cytotechnology 22.4(b) 

Definitions: Cytotechnologist 

License. 

Cytotechnology Licensure. 

Cytotechnologist Competency 

Testing Services Or Programs. 

Enforcement 22.5 

Imposition of Sanctions. 

Principal Sancdons. 

Intermediate Sanctions. 

Alternative Sancfions. 

Automatic Suspension. 

State-Initiated Exclusions from 

Medicaid and Medi-Cal. 

Exclusion from Ownership or 

Operation. 

Civil Suit to Enjoin Violations. 

Criminal Sanctions for Unlawful 

Activity. 

Revocation for Referral of 

Proficiency Testing Samples. 



Page iii 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



§ 1066. 
§ 1067. 

§ 1067.5. 

§ 1067.10. 

§ 1067.15. 



Group 3. 



Article 1. 



§ 1075. 
§ 1076. 
§ 1076.1. 
§ 1077. 
§ 1078. 
§ 1079. 

§ 1080. 
§ 1081. 

§ 1082. 

§ 1083. 
§ 1084. 



Group 4. 



Article 1. 


§ 1125. 
§ 1126. 
§ 1127. 
§ 1128. 
§ 1129. 
§ 1130. 
§1131. 
§1132. 
§ 1133. 
§ 1134. 


Group 5. 


Article 1. 


§ 1150. 


Article 2. 


§ 1151. 


§ 1152. 
§ 1153. 


§ 1154. 


Article 3. 


§ 1155. 
§ 1156. 
§ 1157. 
§ 1158. 


Article 4. 


§ 1159. 


Group 5.5. 


Article 1. 


§ 1160. 


Article 2. 



Page 

Condition Level Requirements. 
Procedures for the Imposition of 
Directed Plans of Conection. 
Procedures for the Imposition of 
Civil Money Penalties. 
Procedures for the Imposition of 
On-site Monitoring. 
Procedures for the Imposition of a 
Temporary Suspension of a 
Laboratoi7 or Clinical Laboratory 
under the Medi-Cal Program. 

County and Municipal 

Laboratories 22. li 

Official Public Health 

Laboratory Service 

Required 22.11 

Local Health Departments. 

Certificates of Approval Required. 

Public Health Laboratory. 

Reports Required. 

Minimum Requirements Specified. 

Professional Personnel to Be 

Certified. 

Professional Training. 

Certain Cultures and Specimens to 

Be Sent to the State Laboratory. 

Certain Specimens to Be Sent to 

Approved Laboratories. 

Inspections to Be Made. 

Health Departments May Contract 

with Private Laboratories. 

Tests for Syphilis Under the 
Premarital and Prenatal Laws 23 

Serologic Tests 23 

Application Required. 

Approved Tests. 

Method of Conducting Tests. 

Evaluation Sera. 

Marriage Health Certificates. 

Persons Permitted to Perform Tests. 

Change of Personnel. 

Change of Director or Location. 

Advertising Prohibited. 

Withdrawal of Approval. 

Care of Laboratory Animals 24 

Definitions 24 

Definitions. 

Certification Requirements 25 

Issuance of the Certificate of 

Approval. 

Fees. 

Application for Renewal of 

Certificate of Approval. 

Records. 

Minimum Standards 25 

Care and Treatment of Animals. 

Quarters. 

Personnel. 

Feeding. 

Filing of Complaint 26 

Filing of a Complaint. 

Methadone Drug Analysis 
Laboratories 26 

Application 26 

Application of Subchapter. 

Definitions 26 



§ 1164. 


§1165. 


§1166. 


§ 1167. 


§ 1168. 


§ 1169. 


§ 1170. 


Article 3. 


§ 1171. 


§ 1172. 


§ 1173. 


§ 1174. 


Article 4. 


§ 1175. 


§ 1176. 


§1177. 


§ 1178. 


§1179. 


§ 1180. 


§ 1181. 



Page 

§1161. Methadone Drug Analysis. 

§ 1162. Methadone Drug Analysis 

Laboratory. 
§ 1163. Methadone Drug Analysis 

Supervisor. 

Method. 

Instrument or Device. 

Sample or Specimen. 

Department. 

May, Shall. 

Methadone. 

Primary Metabohte of Methadone. 

Requirements for Methadone 

Drug Analysis Laboratories 26 

Licensing Requirement. 

Qualifications for Licensing. 

Qualifications of Methadone Drug 

Analysis Supervisor. 

Use or Access of Patients. 

Licensing Procedures 27 

Qualifying for License. 
Renewal of Licenses. 
Application Forms. 
Report of Change or 
Discontinuance. 
License Implications. 
Display of Licenses. 
Fees. 

Article 5. Substances Approved for 
Analysis, Requirements for 
Collection and Handling of 
Samples 27 

§1182. Urine. 

§ 1183. General. 

§ 1 1 84. Sample Preservation. 

Article 6. Methods of Analysis and 

Standards of Performance 28 

§ 1185. General. 

§1186. Standards of Performance. 

§ 1187. Specificity. 

§ 1188. Evaluation of Standards of 

Performance. 
§ 1189. Expression of Analytical Results. 

Article 7. Inspections, Quality 

Control, Proficiency 

Testing 28 

§ 1190. Inspections and Proficiency Testing. 

§ 1191. Access to Premises. 

§ 1192. Quality Control Program and 

Proficiency Testing. 
§1193. Standard of Performance in 

Proficiency Testing Program. 
§ 1 1 94. List of Certified Methad one 

Laboratories. 

Article 8. Records 29 

§1195. General. 

§ 1196. Methadone Drug Analysis 

Laboratory Records. 

Group 6. Water Laboratories 29 

Group 7. Human Tissue Preservation 29 

Article 1 . Approval 29 

§ 1200. Definifions. 

§ 1201. Approval Required for Tissue 

Preservation. 

§ 1202. Provisions for Approval. 

§ 1203. Exemptions from Approval. 

§ 1204. Records. 

§ 1205. Labels. 



• 



• 



Page iv 



(7-25-2008) 



Title 17 



State Department of Health Services 



Table of Contents 



Page 



Group 8. 



Forensic Alcohol Analysis and 



§ 1218. 
§ 1218.1. 
§ 1218.2. 



Article 5. 



§ 1219. 
§ 1219.1. 
§ 1219.2. 
§ 1219.3. 



Article 6. 



§ 1220. 
§ 1220.1. 
§ 1220.2. 
§ 1220.3. 
§ 1220.4. 

Article 7. 

§ 1221. 
§ 1221.1. 
§ 1221.2. 
§ 1221.3. 
§ 1221.4. 
§ 1221.5. 

Article 8. 

§ 1222. 
§ 1222.1. 

§ 1222.2. 
Group 9. 

Article 1. 

§ 1230. 



Article 1. 


General 


§ 1215. 


Authority. 


§ 1215.1. 


Definitions. 


Article 2. 


Requirements for Forensic 




Alcohol Laboratories .... 


§ 1216. 


Authorization Requirement. 


§ 1216.1. 


Qualifications for Licensing. 


Article 3. 


Licensing Procedures 


§ 1217. 


Forensic Alcohol Laboratory 




License. 


§ 1217.1. 


Renewal of Licenses. 


§ 1217.2. 


Application Forms. 


§ 1217.3. 


Report of Change or 




Discontinuance. 


§ 1217.4. 


License Implications. 


§ 1217.5. 


Licensing Records. 


§ 1217.6. 


Inspection and Additional 




Requirements. 


§ 1217.7. 


Surveys and Proficiency Tests. 


§ 1217.8. 


Fees and Other Procedures. 


Article 4. 


Training of Personnel 



30 



30 



31 



32 

Training Program Approval. 
Additional Requirements. 
Contracts. 

Collection and Handling of 

Samples 32 

General. 

Blood Collection and Retention. 

Urine Collection and Retention. 

Breath Collection. 

Methods of Forensic Alcohol 
Analysis 33 

General. 

Standards of Performance. 
Standards of Procedure. 
Quality Control Program. 
Expression of Analytical Results. 

Requirements for Breath 

Alcohol Analysis 34 

General. 

Authorized Procedures. 

Standard of Performance. 

Approved Instruments. 

Standards of Procedure. 

Expression of Analytical Results. 

Records 35 

General. 

Forensic Alcohol Laboratory 

Records. 

Breath Alcohol Analysis Records. 

HIV Antibody Testing 35 

Approval of Laboratories 35 

Approval of Laboratories for Use of 
HIV Antibody Test. 



Chapter 3. Local Health Service 36 

Subchapter 1 . Standards for State Aid 
for Local Health 
Administration 36 

36 



Article 1. 


Organization . . 


§ 1250. 
§ 1251. 

§ 1252. 


Health Officer. 
Office. 
Clerical Staff 



§ 1253. 
§ 1254. 
§ 1255. 
§ 1256. 


Article 2. 


§ 1275. 
§ 1276. 


Article 3. 


§ 1300. 
§ 1301. 
§ 1302. 


§ 1302.1 


§ 1303. 
§ 1304. 
§ 1305. 
§ 1306. 
§ 1307. 
§ 1308. 


Article 4. 


§ 1325. 
§ 1326. 
§ 1327. 
§ 1328. 
§ 1329. 


Subchapter 2. 


Article 1. 


§ 1351. 


§ 1353. 


Article 2. 


§ 1355. 
§ 1357. 
§ 1359. 
§ 1361. 


Article 3. 


§ 1363. 
§ 1365. 


§ 1367. 


§ 1369. 


Article 4. 


§ 1371. 
§ 1373. 
§ 1375. 


Subchapter 3. 


Article 1. 


§ 1401. 
§ 1403. 


Article 2. 


§ 1405. 
§ 1407. 
§ 1409. 
§1411. 
§ 1411.1 
§ 1413. 
§ 1415. 
§ 1417. 
§ 1418. 



Page 

Public Health Nursing Staff 
Environmental Health Staff 
Public Health Laboratory. 
Provisional Approval of Health 
Departments. 

Program 37 

Duties and Functions. 
Basic Services. 

Personnel 38 

Health Officer. 

Director of Public Health Nursing. 

Director of the Public Health 

Laboratory. 

Director of a Branch Public Health 

Laboratoiy. 

Health Flducator. 

Director of Health Education. 

Public Health Nurse. 

Occupational Health Trained Staff 

Occupational Health Sanitarian. 

Director of Environmental Health. 

Finance 40 

Use of Funds. 

Restrictions on Matching Funds. 

Deposit and Expenditure of Funds. 

Budget and Program. 

Reports. 

Standards for State Aid 

for Comprehensive 

Environmental Agencies 41 

Definitions 41 

Comprehensive Environmental 

Agency. 

Environmental Health and 

Sanitation Services and Programs. 

Agency Personnel and 

Facilities 41 

Director of Environmental Health. 

Environmental Health Staff 

Clerical Staff 

Office Facilities. 

Organization 41 

Conditions of Transfer. 

Powers and Duties of the County 

Health Officer. 

Powers and Duties of the District 

Health Officer. 

Powers and DuUes of the Director of 

Environmental Health. 

Program 42 

Basic Program. 
Annual Program Plans. 
State Financial Aid. 

Standards for Maintaining 

County Health Services 42 

Application 42 

Application of Subchapter. 
Section Headings. 

Definitions 43 

Addendum. 

Agreement. 

Allocation. 

Annual Local Jurisdiction Budget. 

Benefits Chart. 

Budget. 

City Health Services. 

County Health Services. 

County Health Services Allocation. 



Page V 



(7 2S 2(H)S) 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Page 



Page 



§ 1419. 
§ 1420.1. 
§ 1420.2. 

§ 1420.3. 

§ 1420.4. 

§ 1420.5. 



County Health Services Fund. 

County Medical Services Program. 

County Medical Services Program 

Account. 

County Medical Services Program 

Contract. 

Declaration of Intent to Enter into 

Contract. 

County Medical Services Program 

Reserve Account. 



§ 1498.6. 
§ 1498.7. 
§ 1498.8. 
§ 1498.9. 



Administration. 
Fiscal. 
Liabilities. 
Reporting. 



§ 1421. 


Department. 


§ 1422. 


Director. 


§ 1 422 . 1 . Eligible (Contract County. 


§1422.3. Eligibility Manual. 


§ 1423. 


Expenditures. 


§ 1425. 


Fixed Assets, Fixtures, Structures 




and Improvements. 


§ 1427 


Inpatient/Outpatient Services. 


§ 1428 


Local .lurisdiction. 


§ 1429 


Maximum Allocation. 


§ 1430 


May, Shall, Should. 


§ 1430.1. Medically Indigent Services 




Account. 


§ 1430 


2. Medically Indigent Services 




Allocation. 


§1430.3. Multi-Yeai- Budget. 


§1430.4. Multi-Yeiu- Plan. 


§ 1431 


Net City Costs for Health Services. 


§ 1432 


Net County Costs for Health 




Services. 


§ 1433 


Plan. 


§ 1435. 


Public Health Services. 


§ 1437. 


Reported Net County Costs for 




Fiscal Year 1977-78. 


§ 1439 


Revenues. 


§ 1440 


"Update." 


Article 3. 


County Health Services 




Multi-Year Plan and Budget 


§ 1445 


Multi-Year Plan and Budget 




Submission. 


§ 1451 


Multi-Year Plan and Budget and 




Update Content. 


§1457 


Plan and Budget Review. 


Article 4. 


Allocations, Agreement, 




Disbursement, Reporting and 




Recoupment Procedures 


§ 1465 


County Health Services Allocation. 


§ 1466 


Medically Indigent Services 




Allocation. 


§ 1467 


Medically Indigent Services 




Application. 


§ 1469 


Agreement. 


§ 1473 


Disbursement. 


§ 1475 


Reports. 


§ 1477 


Recoupment. 


§ 1481 


Special Needs and Priorities. 


Article 5. 


Public Hearing Procedures 


§ 1485 


Purpose. 


§ 1486 


Conditions. 


§ 1487 


Scheduling. 


§ 1489 


Notification. 


§1491 


Conduct. 


§ 1493 


Findings. 


§ 1495 


Transmittal. 


§1497 


Determinations. 


Article 6. 


County Medical Services 




Program 


§ 1498 


County Medical Services Program. 


§ 1498 


I . Declaration of Intent to Contract. 


§ 1498 


2. Small County Advisory Committee. 


§ 1498 


3. Contract. 


§1498 


4. Eligibility. 


§1498 


5. Benefits. 



Article 1. 


Definitions 


§ 1500. 


Indian. 


§ 1501. 


Indian Tribe. 


§ 1502. 


Existing Indian Health Programs. 


§ 1503. 


Direct Health Services. 


§ 1504. 


Licensed Provider of Health 




Services. 


§ 1505. 


Department. 


§ 1506. 


Director. 


§ 1507. 


Indian Medicine and Traditional 




Health Practices. 


Article 2. 


Indian Health Policy Panel 


§ 1520. 


Indian Health Policy Panel. 


§1521. 


Panel Membership. 


Article 3. 


Assistance to Indian Health 




Programs 



52 



52 



§ 1530. 

§ 1531. 

§ 1532. 
§ 1533. 
§ 1534. 
§ 1535. 

Article 4. 

§ 1540. 
§ 1541. 



Financial Assistance to Indian 
Health Programs. 
Allocation of Financial Assistance 
to Indian Health Programs. 
Allocation Formula. 
Reimbursement for Service. 
To Qualify for Funding. 
Criteria for Reimbursement of 
Direct Services. 

Standards of Service 

Confidentiality of Information. 
Informed Consent. 



53 



46 



47 



50 



50 



Chapter 3.5. 



Subchapter 1 . 



§ 2000. 

Chapter 4. 
Subchapter 1. 

Article 1. 

§ 2500. 

§ 2501. 

§ 2502. 

§ 2503. 

§ 2504. 

§ 2505. 
§ 2508. 
§ 2509. 
§ 2510. 

§2511. 

Article 2. 

§ 2512, 
§ 2514 
§ 2515 



Joint Regulations for 

Handicapped Children 59 

Interagency 

Responsibilities for 

Providing Services to 

Handicapped Children 59 

Joint Regulations for Handicapped 

Children. 

Preventive Medical Service 59 

Reportable Diseases and 

Conditions 59 

Reporting 59 

Reporting to the Local Health 

Authority. 

Investigation of a Reported Case, 

Unusual Disease, or Outbreak of 

Disease. 

Reports by Local Health Officer to 

State Department of Public Health. 

Reporting Occurrence ol" Unusual 

Diseases. 

Report by Health Care Provider of 

Out-of-State Laboratory Findings. 

Notification by Laboratories. 

Reporting by Schools. 

Records of Local Health Officer. 

Outbreaks of Nonreportable 

Diseases. 

Determination of Morbidity Level. 

General Instructions 66 

InvestigaUon of the Case. 
Instructions to Household. 
Definition of Isolation. 



Page vi 



(7-2S-2008) 



Title 17 



State Department of Health Services 



Table of Contents 



Page 



Page 



§2516 
§2518 
§ 2520 

§ 2522 
§ 2524 
§ 2526 

§ 2528. 



§ 2530. 
§ 2534. 



§ 2536. 

§ 2538. 
§ 2540. 



Article 3. 



Strict Isolation. 

Modified Isolation. 

Quarantine. 

Observation. 

Terminal Disinfection. 

Exclusion and Readmission by 

School Authorities. 

Contamination by Pathogenic 

Organisms of Milk. Milk Products 

or Products Resembling Milk 

Products. 

Public Food Handlers. 

Laboratory Tests for the Release of 

Cases of Carriers of Communicable 

Diseases. 

Transportation of Conununicable 

Disease Cases. 

Funerals. 

General Clause. 

Specific Diseases and 
Conditions 



67 



§ 2550. 


Amebiasis. 


§2551. 


Anthrax. Cases and Suspect Cases 




to Be Reported by Telephone. 


§ 2552. 


Botulism. Cases and Suspect Cases 




to Be Reported by Telephone. 


§ 2553. 


Brucellosis (Undulant Fever). Cases 




and Suspect Cases to Be Reported 




by Telephone. 


§ 2554. 


Chancroid. 


§ 2555. 


Chickenpox. 


§ 2556. 


Cholera. Cases and Suspect Cases to 




Be Reported by Telephone or 




Telegraph. 


§ 2558. 


Coccidioidomycosis. 


§ 2560. 


Conjunctivitis, Acute Infectious of 




the Newborn. 


§ 2562. 


Dengue. Cases and Suspect Cases to 




Be Reported by Telephone or 




Telegraph. 


§ 2564. 


Diarrhea of the Newborn. 


§ 2566. 


Diphtheria. 


§ 2570. 


Encephahtis, Acute (Including 




Arthropod-Borne Viral, 




Post-Infectious, and Others). 


§ 2572. 


Disorders Characterized by Lapses 




of Consciousness, Alzheimer's 




Disease and Related Disorders. 


§ 2574. 


Food Poisoning. 


§ 2575. 


German Measles (Rubella). 


§ 2577. 


Gonococcus Infection. 


§ 2578. 


Granuloma Inguinale. 


§ 2579. 


Hepatitis, Infectious. 


§ 2580. 


Influenza, Epidemic. 


§2581. 


Hepatitis, Serum (Homologous 




Serum Jaundice). 


§ 2582. 


Leprosy (Hansen's Disease). 


§ 2584. 


Leptospirosis (Including Weil's 




Disease). 


§ 2585. 


Lymphogranuloma Venereum. 


§ 2586. 


Malaria. 


§ 2588. 


Measles. 


§ 2590. 


Meningitis, Meningococcal or 




Meningococcemia. 


§ 2592. 


Mumps. 


§ 2593. 


Neoplasm, Cancer. 


§ 2594. 


Pertussis (Whooping Cough). 


§ 2595. 


Physically Handicapped Children 


§ 2596. 


Plague. Cases and Suspect Cases to 




Be Reported by Telephone. 


§ 2597. 


Q Fever. 


§ 2598. 


Pneumonia, Infectious (Except 




Pneumonic Plague). 


§ 2600. 


Poliomyelitis, Acute Anterior. 


§ 2602. 


Psittacosis. 



§ 2603. 


Control of Pet Birds. 


§ 2603.5. 


Control of Psitlacine Birds. 


§ 2604. 


Rabies, Human. 


§ 2606. 


Rabies, Animal. 


§ 2606.2. 


Rabies Quarantine. 


§ 2606.4. 


Officially Declared Rabies Areas. 


§ 2606.6. 


Importation of Dogs. 


§ 2606.8. 


Skunk Rabies. 


§ 2608. 


Relapsing Fever. 


§2610. 


Rheumatic Fever, Acute. 


§2611. 


Rocky Mountain Spotted Fever. 


§2612. 


Salmonella Infections (Other Than 




Typhoid Fever). 


§2612.1. 


Turtle Salmonellosis. 


§2613. 


Shigella Infections (Dysentery, 




Bacillary). 


§ 2614. 


Smallpox (Variola). Cases and 




Suspect Cases to Be Reported by 




Telephone. 


§ 2616. 


Streptococcal Infections, Hemolytic 




(Including Scarlet Fever and 




Streptococcal Sore Throat). 


§2617. 


Syphilis. 


§ 2618. 


Tetanus. 


§ 2620. 


Trachoma. 


§ 2622. 


Trichinosis. 


§ 2624. 


Tuberculosis. 


§ 2626. 


Tularemia. Cases and Suspect Cases 




to Be Reported by Telephone. 


§ 2628. 


Typhoid Fever. 


§ 2630. 


Typhus Fever (Flea-Borne, 




Endemic Type). 


§ 2632. 


Typhus Fever (Louse-Borne, 




Epidemic Type). Cases and Suspect 




Cases to Be Reported by Telephone 




or Telegraph. 


§ 2636. 


Venereal Diseases. 


§ 2638. 


Viral Hemorrhagic Fevers (e.g.. 




Crimean-Congo, Ebola, Lassa and 




Marburg Viruses). Cases and 




Suspect Cases to Be Reported by 




Telephone. 


§ 2640. 


Yellow Fever Cases and Suspect 




Cases to Be Reported by Telephone 




or Telegraph. 



Article 3.5. Reporting of Human 

Immunodeficiency Virus 

(HIV) Infection 76.2 

Subarticle 1. Definitions 76.2 

§ 2641.5. Alternative Testing Site. 

§ 2641.10. Anonymous Counseling and Testing 

Program. 
§ 2641.15. Anonymous HIV Test. 

§ 2641.20. Biological Specimen. 

§ 2641 .25. Confidential HIV Test. 

§ 2641 .30. Confirmed HIV Test. 

§2641.35. Department. 

§ 2641 .45. Health Care Provider. 

§ 2641 .50. Health Officer and Local Health 

Officer. 
§ 2641 .55. HIV/AIDS Case Report. 

§ 2641.56. HIV/AIDS Confidentiality 

Agreement. 
§ 2641.57. HIV Test Algorithm. 

§ 2641.60. Laboratory. 

§ 2641.65. Laboratory Test. 

§ 2641.70. Local Health Department. 

§ 2641.75. Non-Name Code. [Repealed] 

§ 2641 .77. Partial Non-Name Code. 

[Repealed] 
§2641.80. Personal Information. 

§ 2641 .85. Publicly-Funded Confidential 

Counseling and Testing Program. 
§2641.90. SoundexCode. 



Page vii 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Subarticle 4 


Reporting Requirements 


§ 2643.5. 


HIV Reporting by Health Care 




Providers. 


§2643.10 


'. HIV Reporting by Laboratories. 


§2643.15 


HIV Repining by Local Health 




Officers. 


§ 2643.20 


'. HIV Reponing Exemptions. 


Article 4. 


Approval Procedures for 




Canine Rabies Vaccines 


§ 2650. 


Canine Rabies Vaccine Advisory 




Committee. 


§2651. 


Approval of Canine Rabies 




Vaccines. 


§ 2652. 


Immunity Duration-Challenge 




Studies. 


§ 2653. 


Origin and Integrity of Rabies 




Vaccine Virus. 


Subchapter 2. 
Subchapter 2.5. 


Adult Health 


Disorders Characterized 




by Lapses of 




Consciousness 


Article 1. 


Definitions 


§ 2800. 


Activities of Daily Living. 


§ 2802. 


Alzheimer's Disease and Related 




Disorders. 


§ 2804. 


Diagnose. 


§ 2806. 


Disorders Characterized by Lapses 




of Consciousness. 


§ 2808. 


Sensory Motor Functions. 


Article 2. 


Reporting 


§2810. 


Reporting Requirements. 


§2812. 


Exceptions to Reporting. 


Subchapter 3. 


Services for Physically 



Page 



76.4 



Page 



76.6 



76.8 



76.8 



76.8 



76.8 



Group 1. 



Handicapped Children 76. 

Minimum Standards for the Care 
of Physically Handicapped 
Children for Local 





Communities in California 


. 76. 


Article 1. 


General 


. 76. 


§ 2890. 


Confidential Nature of Crippled 
Children's Records. 




§ 2900. 


Case Finding and Reporting. 




§2901. 


Definition. 




§ 2902. 


Records and Reports. 




§ 2903. 


Diagnostic Services. 




§ 2904. 


Treatment. 




§ 2905. 


After-Care Services. 




§ 2906. 


Authorizafion for Services. 




Article 2. 


Immunization Adverse 






Reaction Fund 


. 76. 


§ 2907. 


Bone Marrow Transplantation for 
Cancer. 




§2910. 


Program Administration. 




§2912. 


Use of Fund. 




§2914. 


Extensive Medical Care. 





Article 3. Podiatrist and Family 
Practice Physician 
Services 76.9 

California Children Services (CCS). 

California Children Services (CCS) 

Panel. 

Expertise in the Care of Children. 

General Supervision. 

Article 4. Genetically Handicapped 

Persons Program 76.10 



§ 2920. 
§2921. 

§ 2922. 
§ 2923. 



§ 2930. 
§2931. 

§ 2932. 


Genetically Handicapped Persons 

Program. 

California Children 

Services/Genefically Handicapped 

Persons Program Special Care 

Center. 

Medical Eligibility — Conditions. 




Group 2. 


Registration as School 






Audiometrists 


...77 


Article 1. 


General 


...77 


§ 2950. 
§2951. 


Qualifications. 
Testing Standards. 




Subchapter 4. 


The Infant Botulism 
Treatment and Prevention 






Program 


. 78.1 


Article 1. 


Definitions 


. 78.1 


§ 3000.2. 
§ 3000.4. 


Botulism Immune Globulin. 
Infant Botulism Treatment and 





Article 2. 

§ 3010. 
Article 3. 

§ 3020. 



Prevention Program. 
Distribution of Botulism 
Immune Globulin 

Distribution of Botulism Immune 
Globulin. 



78.1 



Reporting Requirements for 
Hospitals Receiving BIG 78.1 

Reporting Requirements for 

Hospitals. 



Article 4. 


Fees 


78.1 


§ 3030. 


Fee. 




Subchapter 5. 


Public Health Nursing 


.. 79 


Group 1. 


Public Health Nursing 


.. 79 


Article 1. 


Issuance of Public Health 






Nursing Certificates 


.. 79 


§ 4500. 


Public Health Nurse Certificate. 




§4501, 


Qualifications and Requirements. 




§ 4502. 


AppUcation for Public Health Nurse 
Certificate. 




§ 4503. 


Issuance of Application. 




§ 4504. 


Appeal Process. 




Group 2. 


Trained Attendants 


.. 79 


Subchapter 6. 


Tuberculosis Hospitals 
and Sanatoria Receiving 






State Subsidy 


.. 79 


Subchapter?. 


Venereal Diseases 


.. 79 


§5151. 


Sexually Transmitted Diseases in 
Minors. 




Subchapter 8. 


Immunization Against 





Article 1. 

§ 6000. 
§ 6010. 
§ 6015. 

Article 2. 

§ 6020. 



Poliomyelitis, 
Diphtheria, Pertussis, 
Tetanus, Measles 
(Rubeola), Rubella, 
Haemophilus Influenzae 
Type B (Hib), Mumps, and 
Hepatitis B 

Definitions 

Admission. 
Immunizing Agent. 
Pupil. 

Required Immunizations 
Required Immunizations. 



79 
79 



80 



Page viii 



(7-25-2008) 



Title 17 



State Department of Health Services 



Table of Contents 



Page 



Page 



Article 3. Admission to School, Child 

Care Center, Day Nursery, 
Nursery School, Family Day 
Care Home, or Development 

Center 82 

§ 6025. Unconditional Admission. 

§ 6030. Conditional Admission to 

Prekindergarten Level. 
§ 6035. Conditional Admission. 

§ 6040. Requirements for Continued 

Attendance. 
§ 6045. Special Immunization Schedules. 

§ 6050. Conditional Admission with 

Temporary Medical Exemption. 
§ 6051. Unconditional Admission with 

Permanent Medical Exemption or 
Personal Beliefs Exemption. 

Article 4. Exclusion 85 

§ 6055. Conditions for Admission Not 

Fulfilled. 
§ 6060. Pupil Not Completely Immunized 

and Exposed to Communicable 

Disease. 

Article 5. Records As Evidence of 

Immunization 86 

§ 6065. Documentary Proof. 

§ 6070. School/Child Care Facility 

Immunization Record. 
§ 6075. Reporting. 

Subchapter 8.1. Immunization Against 

Measles (Rubeola) 87 

Subchapter 8.2. Immunization Against 
Diphtheria, Tetanus, and 
Pertussis 87 

Subchapter 9. Testing for Heritable 

Disorders 87 

Group 3. Newborn Screening Program 87 

Article 1 . Definitions 87 

§ 6500. Birth Attendant. 

§6500.1. Days of Age. 

§ 6500.5. Discharge. 

§6500.19. Inadequate Specimen. 

§ 6500.25. Initial Positive Test. 

§ 6500.28. Initial Specimen. 

§6500.31. Initial Test. 

§ 6500.35. Newborn. 

§ 6500.39. Newborn's Physician. 

§ 6500.45. Newborn Screening Area Service 

Center. 

§ 6500.46. Newborn Screening Laboratory. 

§ 6500.57. Perinatal Licensed Health Facility. 

§ 6500.59. Preventable Heritable or Congenital 

Disorder. 

§ 6500.65. Recall Specimen. 

§ 6500.67. Recall Test. 

§ 6500.69. Repeat Specimen. 

§ 6500.70. Repeat Test. 

§ 6500.74. Sickle Cell Counselor. 

§ 6500.77. Sickle Cell Education and 

Counseling Program. 

§ 6500.80. Transfer. 

Article 2. Testing and Follow-Up 

Program Requirements 89 

§ 6501. Scope of Newborn Testing. 

§ 6501.2. Religious Objection. 

§ 6502. Fatal Condition. 



§6502.1. 


Confidentiality. 


§ 6503. 


Newborn Screening Laboratory 




Requirements. 


§ 6504. 


Parent Education: Birth Attendants. 


§ 6504.2. 


Parent Education: Perinatal 




Licensed Health Facilities. 


§ 6504.4. 


Specimen Collection Forms. 


§ 6504.6. 


Record Maintenance. 


§ 6505. 


Collection of Specimens. 


§ 6506. 


Medical Record Review. 


§ 6506.2. 


Newborns Discharged from a 




Perinatal Licensed Health Facility 




Without Testing. 


§ 6506.6. 


Follow-Up to Reports of Inadequate 




Specimen. 


§ 6506.8. 


Follow-Up to Reports of Initial 




Positive Result. 


§6506.10. 


Repeat and Recall Specimen 




Collection and Transmittal. 


§6506.12. 


Diagnosis Reporting. 


§ 6507. 


Failure to Comply. 


§6507.1. 


Local Agency Responsibilities. 


Article 3. 


Sickle Cell Programs 92 


§ 6507.2. 


Sickle Cell Education and 




Counseling Program Requirements. 


§ 6507.3. 


Certification of a Sickle Cell 




Counselor. 


§ 6507.4. 


Voluntary Participation. 


§ 6507.5. 


Informed Consent. 


§ 6507.6. 


Approval of Hemoglobin Testing 




Laboratories. 


§ 6507.7. 


Sickle Cell Trait Can-ier Follow-Up 




Vendor. 


Article 4. 


Newborn Screening 




Participation Fee 93 


§ 6508. 


Newborn Screening Fee Collection. 


§6510. 


Rhesus (Rh) Hemolytic Disease of 



the Newborn. 



Group 5. 



Prenatal (Multiple Marker) 

Testing Program 94 



icle 1. 


Definitions 94 


§6521. 


Alpha-Fetoprotein. 


§6521.3. 


Analyte. 


§6521.5. 


Birth Defect. 


§6521.7. 


Clinician. 


§6521.9. 


Differential Diagnostic Screening 




Tests and Procedures. 


§6521.11. 


Expanded AFT Follow-Up Vendor. 


§6521.13. 


Expanded AFP Prenatal Birth 




Defects Screening Laboratory. 


§6521.15. 


Expanded AFP Prenatal Screening 




for Birth Defects. 


§6521.17. 


Gestational Age. 


§6521.19. 


Inadequate Specimen. 


§6521.21. 


Initial Screening Positive Test. 


§6521.23. 


Initial Specimen. 


§6521.25. 


Method. 


§6521.27. 


Neural Tube Defect. 


§6521.29. 


Prenatal Diagnosis Center. 


§6521.31. 


Repeat Specimen. 


icle 3. 


Testing and Follow Up 




Program Requirements 94.2 


§ 6523. 


Expanded AFP Prenatal Birth 




Defects Screening Laboratories and 




Analytical Methods. 


§ 6525. 


Prenatal Diagnosis Centers and 




Laboratories. 


§ 6527. 


Clinician Requirements. 


§ 6529. 


Rhesus (Rh) Hemolytic Disease. 


§6531. 


Reporting of Neural Tube Defects. 


§ 6532. 


Reporting of Chromosomal 




Disorders. 



Page ix 



(7 25 2(l()Sl 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Article 4. 



§ 6540. 
§6540.1 



Subchapter 10. 



Article 1. 

§ 6600. 
§6601. 
§ 6602. 
§ 6603. 
§ 6604. 
§ 6605. 
§ 6606. 
§ 6607. 

Article 2. 



§ 6608. 

Subchapter 11. 



Article 1. 

§6701. 
§ 6702. 

Article 2. 

§ 6705. 

Article 3. 

§6710. 
§6711. 
§6712. 
§ 6714. 
§ 6715. 
§6716. 

Article 4. 

§ 6720. 
§6721. 

§ 6722. 

Subchapter 12. 

Subchapter 13. 



Article 1. 

§ 6800. 
§6801. 
§ 6802. 

§6804. 
§ 6806. 
§ 6808. 
§6810. 
§6812. 
§6813. 
§ 6814. 
§6816. 
§6817. 
§6818. 



Page 

Prenatal Screening Fee 

Collection 94.3 

Program Participation Fee. 

Prepaid Group Practice Plan. 

Tuberculosis Screening of 

Employees and Volunteers 

in Private, Parochial 

and Nursery Schools 94.4 

Definitions 94.4 

Employee. 
Volunteer. 

Private and Parochial Schools. 
Nursery School. 
Elementary School. 
Secondary School. 
Minimum Examination. 
Approved Skin Test. 

Records as Evidence of 

Compliance 94.4 

Records as Evidence of 

Compliance. 

First Aid and 

Cardiopulmonary 

Resuscitation Training 

Standards for Public 

Safety Personnel 94.4 

General 94.4 

Application and Scope. 
Time Limitation for Training. 

Definitions 94.4 

Definitions. 

Training Standards 94.4 

Scope of Course. 

Required Topics. 

Special Requirements. 

Testing. 

Validation of Course Completion. 

Retraining Requirements. 

Designated Agencies 95 

Course Approval. 
Additional Requests for 
Designation. 
Program Review. 

Ambulance Personnel 95 

Child Health and 

Disability Prevention 

Program 95 

Definitions 95 

Health Assessment. 

Conrmiunity. 

Community Child Health and 

Disability Prevention Program. 

Contract Counties. 

Department. 

Diagnosis. 

Director. 

Governing Body. 

Initiation of Treatment. 

Medi-Cal Beneficiary. 

Person. 

Clinical Laboratory. 

Screening. 



Page 

§ 68 1 9. Child Health and Disability 

Prevention Services in Contract 
Counties. 

Article 2. Program Administration 97 

§ 6820. Advisory Boards. 

§ 6822. Director and Deputy Director. 

§ 6824. State and Local Responsibilities. 

§ 6826. State and Local Information and 

Training Responsibilities. 

§ 6828. Sanctions for Noncompliance. 

Article 3. Eligibility for Services and 

Reimbursement 99 

§ 6830. Eligibility for Services. 

§ 6832. Eligibility for Reimbursement. 

Article 4. Required Services 100 

§ 6840. Required Services. 

§ 6842. Outreach and Health Education. 

§ 6843. Referral to Dentist. 

§ 6844. Referral to Health Assessment. 

§ 6846. Health Assessment. 

§ 6847. Periodicity of Health Assessments. 

§ 6848. Certification for School Entry. 

§ 6850. Referral to Diagnosis and 

Treatment. 

§ 6852. Diagnosis and Treatment. 

Article 5. Providers of Health 

Screening and Evaluation 

Services 104 

§ 6860. Condidons of Participation. 

§ 6862. Types of Providers. 

Article 6. Claiming for Services 105 

§ 6866. Procedures. 

§ 6868. Schedule of Maximum Allowances. 

Article 7. Records, Reporting and 

Confidentiality 106 

§ 6870. Records. 

§ 6872. Reporting. 

§ 6874. Confidentiality. 

Subchapter 1 4. Stop Tobacco Access to 

Kids Enforcement (STAK13) 

Act Program 107 

§6901. Definitions. 

§ 6902. Warning Sign; Identificafion. 

§ 6903. Inspections; Decoys. 

§ 6904. Defenses. 

§ 6905. Annual Report of Tobacco Retail 

Sites. 

Chapters. Sanitation (Environmental) 108.1 

Subchapter 1. Engineering (Sanitary) 108.1 

Group 1 . Domestic Water Supplies 

Quality and Monitoring 108.1 

Group 1.1. Waterworks Standards 108.1 

Group 2. Certification of Water 

Treatment Facility Operators 108.1 

Article 1. General 108.1 

§ 7100. Purpose. 

§7101. Definition. 

Article 2. Responsibility of Water 

Supplier 108.1 

§ 7103. Employment of Certified Operator. 

§ 7104. Operator-in-Training. 

§7105. Remote Area. 

Article 3. Responsibility of Operators 108.1 



Page 



(7-25-2008) 



Title 17 



State Department of Health Services 
Page 

Certification Requirements. Article 3. 

Grade of Operator. 

Issuance of Certificates 108.1 

Requirements for Certification. § T17-7603 

Application. § T 17-7604 
Processins an Application for A t' ^ A 
Certification. Article 4. 
Processing Time. 

Application Review. § j \ 7_76 1 5 

Notification to Applicants. § T17-7616 

Certification Without Examination § T 17-76 17 

for Certain Persons Employed Prior § Tl 7-76 18 
to April 30, 1973. 

Minimum Qualifications for § T 17-76 19 

Examination. § T 17-7620 

^ r^ -,- . §117-7621 

Types 01 Certiiication 108.2 

Regular Certification. § T 17-7622 

Temporary Certification. a t' 1 '> 

Limited Certification. Article D. 

Certification Issuance, § 7523. 

Renewal, Suspension and § 7624. 

Revocation 108.2 ^ l?z^^ 

8 7626. 
Issuance and Renewal. s 7577 

Suspension for Failure to Renew s -7^28 

Certificate. ^ -7^29 

Revocation of Certificate. 
Posting of Certificate. §7630 

Examination 108.3 

Frequency of Examinations. Article 1 1 . 

Examination Content. 
Examination Procedure. 

Fees 108.3 

Application Fee. 

Renewal Fee. 

Reexamination Fee. Article 12. 

Penalty Fee. 

Duplicate Certificate Fee. 

Group 5. 

Drain Wells 108.4 

Article 1. 

Drain Wells 108.4 § 7706. 

Drain Wells. 

§ 7707. 

Drinking Water Supplies 109 

§ 7708. 

General 109 

Definitions. ^ __„„ 

„ § 7709. 

Purpose. 

Responsibility and Scope of s 771 fl 

Program. s 7711 

Evaluation of Hazard. X nn^-^ 

TIC- 8 7712. 

User Supervisor. I 77 n 

Cross-Connecfion . 

Approved Water Supply. 

Auxiliary Supply. S 7714 

Approved Check Valve. 

Approved Double Check Valve 

Assembly. Article 2. 

Air-Gap Separation. 

Approved Reduced Pressure 

Principle Backflow Prevention ^ /719. 

Device. 

§ 7720. 

Protection of Water System 110 

Approval of Backflow Preventers. Article 3. 

Construction of Backflow s 7725. 

Preventers. 

Locafion of Backflow Preventers. Article 4. 

Type of Protection Required. §7730. 

Testing and Maintenance of 

Backflow Preventers. § 7731. 



Table of Contents 



§7106. 
§7107. 

Article 4. 

§ 7109. 
§7110. 
§7110.1. 

§7110.2. 
§7111. 
§7112. 
§7113. 



§7114. 

Article 5. 

§7116. 
§7117. 
§7118. 

Article 6. 



§7120. 
§7121. 

§7122. 
§7123. 

Article 7. 

§7125. 
§7126. 
§7127. 

Article 8, 

§ 7130. 
§7131. 
§7132. 
§7133. 
§ 7134. 

Group 3. 

Article 1. 

§ 7557. 

Group 4. 

Article 1. 

§ 7583. 
§T1 7-7583 
§ 7584. 

§ 7585. 
§ 7586. 
§ T 17-7588 
§ Tl 7-7589 
§ T 17-7590 
§T1 7-7591 
§ T 17-7592 

§ T 17-7593 
§TI 7-7594 



Article 2. 

§7601. 
§ 7602. 

§ 7603. 
§ 7604. 
§ 7605. 



Page 

Protection of Public Water 

System at Service 

Connection 112 

Where Protection Is Required. 

Type of Protection. 

Protection of Potable Water 

System Within Premises 112 

Separate Drinking Water Systems. 

Fire System. 

Process Waters. 

Sewage Treatment Plants and 

Pumping Stations. 

Plumbing Connections. 

Pier and Dock Hydrants. 

Marking Safe and Unsafe Water 

Lines. 

Water Supervisor. 

Domestic Water Supply 

Reservoirs 112 

Intent of Regulations. 

Application of Regulations. 

Definitions. 

Application for Permit. 

Data to Accompany Application. 

Guides to Evaluating Application. 

Reservoirs for Which Permits May 

Be Granted. 

Kinds of Recreational Use Allowed 

or Prohibited. 

Delegation of Authority 

Pursuant to Section 4025 of 

the Health and Safety Code 

(Permits for Small Water 

Systems) 113 

Production and Distribution 

of Bottled Water 113 

Sanitary Control of Shellfish 113 

Shellfish Certificates 113 

Shellfish Bed Certificate Issuable by 

the State Board of Public Health. 

Shellfish Plant Certificate Issuable 

by the State Board of Public Health. 

Authority of State Board of Public 

Health to Revoke or Suspend 

Certificate. 

Expiration and Renewal of 

Certificates. 

Definition. 

Types of Certificates. 

Application for Certificate. 

No Shellfish Grown in the State of 

California to Be Sold or Distributed 

Unless Certified. 

No Shucked Shellfish to Be Sold or 

Distributed Unless Certified. 

Safety of Shellfish and 

Health of Employees 114 

Safety of Shellfish for Human 

Consumption. 

Persons Infected With 

Communicable Diseases. 

Records 114 

Record of Operations. 

Shellfish Beds 1 14 

Cleanliness of Shellfish Growing 

Areas. 

Boat Sanitation. 



Page xi 



(7 2^ 2(H)S) 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



§ 7732. 

§ 7733. 

Article 5. 

§ T 17-7738 
§ 7739. 
§ 7740. 
§7741. 
§ 7742. 

§ 7743. 
§117-7744 
§ 7745. 
§117-7746 
§117-7747 
§ T 17-7748 
§117-7749 
§ T 17-7750 
§117-7751 
§ T 17-7752 
§ 7753. 
§ 7754. 
§ 7755. 

§ 7756. 
§ 7757. 
§ 7758. 
§ 7759. 
§ 7760. 
§7761. 
§ 7762. 

Group 6. 
Group 7. 

Article 1. 

§7861. 

Article 2. 

§ 7862. 

Article 3. 

§ 7863. 

Article 4. 

§ 7864. 
§ 7865. 
§ 7866. 

§ 7867. 
§ 7868. 

Article 5. 

§ 7869. 

Article 6. 

§ 7870. 
§7871. 
§ 7872. 
§ 7873. 
§ 7874. 
§ 7875. 

§ 7876. 
§ 7877. 
§ 7878. 
§ 7879. 
§ 7880. 
§7881. 
§ 7882. 
§ 7883. 



Page 

Shellfish from Uncertified Aieas 
Brought into Certified Beds. 
Water Quality. 

Plants and Operations 114 

Culling Plants. 

Storage. 

Cleanliness of Shellstock. 

Shipping. 

Shucking and Packing Plants and 

Equipment. 

Washing. 

Plant Anangement. 

Floors. 

Walls and Ceilings. 

Screening. 

Light. 

Ventilation. 

Toilet Facilities. 

Handwasliing Facilities. 

Sewers and Drains. 

Water Supply. 

Benches and Stands. 

Construction of Utensils and 

Equipment. 

Aprons and Finger Cots. 

Refrigeration. 

Ice. 

Cleaning. 

Sterilization of Equipment. 

Packing and Shipping. 

Repacking Shucked Stock. 

Public Swimming Pools 116 

Bottled Water and Water 

Vending Machines 116 

Water Bottler and Water 

Vendor Responsibilities 116 

General. 

Definitions 116 

Definitions. 

Water Quality 116 

Bottled and Vending Machine Water 
Quality. 

Good Manufacturing 

Practices 116 

Water Bottling Plants. 

Water Vending Machines. 

Cleaning and Sanitizing of 

Containers. 

Water Dispensers. 

Labels and Advertising. 

Out-of-Stale Bottler or 

Distributor 117 

Apphcations. 

Licenses and Fees 117 

Licenses. 

Doors and Windows. 

Toilet — Handwashing Facilities. 

Plant Maintenance. 

Personnel — Cleanliness . 

Cleaning and Sanitizing of 

Containers. 

Filling and Closures. 

Dry Storage. 

Water Dispensers. 

Water Vending Machines. 

Records. 

Labels and Signs. 

Applications. 

Licenses. 



Group 8. 


Article 1. 


§ 7925. 


Article 2. 


§ 7933. 


§ 7934. 


§ 7935. 


§ 7936. 


§ 7937. 


Group 9. 


Article 1. 


§7941.1. 


Article 2. 


§7941.2. 


§7941.3. 


Article 3. 


§7941.4. 


Article 4. 



§7941.5. 
§7941.6. 

§ 7942. 
Article 5. 



§ 7943. 

§ 7944. 
§ 7945. 
§ 7946. 



Group 10. 



Article 1. 


Article 2. 


§ 7952. 


§ 7953. 
§ 7954. 
§ 7955. 
§ 7956. 


Article 3. 


Article 4. 


§ 7957, 
§ 7958. 
§ 7959. 
§ 7960. 
§7961. 



§ 7962. 

Article 5. 
Group 10.1. 



Page 

Sanitary Inspections 118 

Sale of Rat Exterminators 118 

Sale of Rat Exterminators. 
Capture, Holding, Shipment 
and Sale of Wild Rodents 118 

Definitions. 

Registration. 

Disinfeslation, Quarantine and 

Shipment of Wild Rodents. 

Reports. 

Disposition of Trapped Wild 

Rodents. 

Registered Sanitarians GTP 119 

Internship Program 119 

Internship Program. 

Approval of Educational 

Institutions 119 

Approved Educational Institution. 

Review of Curriculum. 

Registration Procedures 119 

Certification of Registration. 

Minimum Educational and 
Experience Qualifications 
for Admission to the 
Examination for Registered 
Sanitarians 119 

Educational and Experience 

Requirements. 

Cross-Certification with 

Department of Food and 

Agriculture. 

Excepdons. 

Application Procedures for 
Sanitarian Registration 120 

Application Submission, 

Completion and Nofification. 

Application Review Period. 

Apphcation Decision Period. 

Median, Minimum, and Maximum 

Application Processing Times. 

Sanitation, Healthfulness and 

Safety of Ocean Water-Contact 

Sports Areas 120 

Intent of Regulations 120 

Definitions 120 

Public Water-Contact Sports Area 

Defined. 

Public Beach Defined. 

Safety Program Defined. 

Refuse Defined. 

Storm Drain. 

Sanitation 120 

Healthfulness 120 

Physical Standard. 
Bacteriological Standards. 
Bacteriological Sampling. 
Corrective Action. 
Pubhc Beaches Visited by More 
Than 50,000 People Annually and 
Adjacent to Storm Drains. 
Duties Imposed on a Local Public 
Officer or Agency. 

Safety 121 

Sanitation of Public Beaches 121 



Page xii 



(7-25-2008) 



Title 17 



State Department of Health Services 



Table of Contents 



Page 



Page 



Article 1. Intent of Regulations 121 

Article 2. Definitions and Exemptions 121 

§7971. Beach. 

§ 7972. Saltwater Body. 

§ 7973. Freshwater Body. 

§ 7974. Refuse. 

§ 7975. Sanitation. 

§ 7976. Recreational Purposes. 

§ 7977. Public Health and Safety. 

§ 7978. Health Officer. 

§ 7979. Exemption. 

§ 7980. Review by Health Officer. 

Article 3. Day Use Beaches 122 

§7981. Application. 

§ 7982. Toilets. 

§ 7983. Water Supply. 

§ 7984. Maintenance. 

§ 7985. Refuse Handling. 

§7985.1. Animals. 

§ 7986. Implementation. 

Article 4. Beaches Allowing Overnight 

Camping 122.1 

§ 7987. Application. 

§ 7988. Refuse Handling. 

§7988.1. Animals. 

§ 7989. Campsites. 

§ 7990. Sanitary Facilities. 

§ 7991. Maintenance. 

§ 7992. Disposal of Sewage Wastes. 

§ 7993. Laundry Facilities. 

§ 7994. Water Supply. 

Group 1 1 . Food Crop Growing and 

Harvesting Sanitation 123 

Article 1. Intent of Regulations 123 

§ Tl 7-8000. Intent of Regulations. 

Article 2. Definitions 123 

§T1 7-8001. Food Crop. 

§ T17-8002. Privacy, 

§ 8003. Toilet Facilities. 

Article 3. Toilet Facilities 123 

§ 8004. General Standards. 

§ 8005. Chemical Toilet Standards. 

Article 4. Servicing of Units 123 

§ 8006. Suitable Chemicals. 

§ 8007. Disposal of Contents of Chemical 

Tanks. 

§ 8008. Standards. 

§ 8009. Privies. 

§ 8010. Toilets. 

Article 5. Supplies 124 

§ 80 1 1 . Toilet Paperholder. 

Article 6. Handwashing Facilities 124 

§ 8012. Standards. 

Article 7. Waste Wash Water Disposal 124 

§ 801 3. Water Flush Toilets and 

Handwashing Facilities. 

Group 12. Reclaimed Waste Water 124 

§ 8025. Intent. 

Subchapter 1.5. Regulations for 

Implementation of the 

California Environmental 

Quality Act of 1970 124 

Subchapter 2. Foods and Drugs 124 

Group 1 . Rules and Regulations 124 



§ 10101. 


Order Promulgating Regulations. 


§ 10102. 


General Regulations. 


§ 10103. 


Constitutionality. 


§ 10150. 


Cosmetic Regulations. 


Article 1. 


Definitions 125 


§ 10200. 


Dietary Supplement. 


Article 2. 


Drugs and Devices 




Regulations 125 


§ 10350. 


Labeling Defined (26207). 


§ 10355. 


Truth of Labeling (26208). 


§ 10360. 


New Drugs — Definition. 


§ 10365. 


Drugs— Name (26230). 


§ 10370. 


Poisonous In.secticides and 




Rodenticides, Use of (26234(2)). 


§ 10371. 


Drugs: Current Good Manufacturing 




Practice in Manufacture, Processing, 




Packaging, Labeling or Holding 




(26234(3)). 


§ 10375. 


Blending of Certified Coal Tar 




Colors (26235 (2)). 


§ 10376. 


Drug and Device Manufacturing 




Licenses. 


§ 10377. 


Definitions. 


§ 10377.1. 


Qualifications. 


§ 10377.2. 


Revocation and Suspension. 


§ 10377.3. 


Compliance. 


§ 10377.4. 


Requirements for the Storage and 




Handling of Human Prescription 




Drugs. 


§ 10377.5. 


Requirements for the Establishment 




and Maintenance of Human 




Prescription Drug Records. 


§ 10377.6. 


Written Policies and Procedures for 




the Handling of Human Prescription 




Drugs. 


§ 10377.7. 


Inspection by Federal, State, and 




Local Law Enforcement Officials. 


§ 10377.8. 


Manufacturers of Active Ingredient 




Components of Human Prescription 




Drugs. 


§ 10380. 


Labeling, Misbranding (26240). 


§ 10381. 


Label Non-Prescription Drugs. 




Pregnancy/Nursing. 


§ 10385. 


Labeling Requirements (26241). 


§ 10386. 


Manufacturer of Finished Dosage 




Form. 


§ 10390. 


Forms of Making Required 




Statements (26242). 


§ 10395. 


Statements of Ingredients and 




Proportions (26243). 


§ 10400. 


Hoxsey Method for Treatment of 




Cancer. 


§ 10400.1. 


Beta-Cyanogenetic Glucosides 




("Laetriles") Agent for Treatment of 




Cancer. 


§ 10400.2. 


Bolen Test for Diagnosis of Cancer. 


§ 10400.3. 


Koch Agents for Treatment of 




Cancer. 


§ 10400.4. 


Lincoln Staphage Lysate Agent for 




Treatment of Cancer. 


§ 10400.5. 


Mucorhicin Agent for Treatment of 




Cancer. 


§ 10400.6. 


Anthrone Test for Diagnosis of 




Cancer. 


§ 10400.7. 


Krebiozen for Treatment of Cancer. 


§ 10401. 


Drugs for Use in the Diagnosis, 




Treatment, Alleviation or Cure of 




Cancer in Human Beings. 


§ 10401.1. 


Investigation of Various Agents for 




the Diagnosis or Treatment of 




Cancer. 


§ 10401.2. 


American Board of Oncology. 


§ 10405. 


Directions for Use — FIxemptions 




Thereto. 


§ 10409. 


Prescription Ophthalmic Devices. 


§ 10410. 


Exemption for Prescription Devices. 



Page xiii 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Page 



Page 



§ 10415. 


E.xemption for Prescription Dnigs 




and Veterinary Drugs, 


§ 10416. 


Exemptions for Drugs Dispensed by 




Licensed Practitioners. 


§ 10417. 


Formulary of Inequivalent Generic 




Drug Types and Drug Products for 




Which Substitution Poses a Threat 




to Health and Safety. 


§ 10420. 


Label Requirements (26254). 


§ 10425. 


Applications. 


§ 10430. 


Notification of AppHcant (26289), 


§ 10435. 


Insufficient Information in 




Application (26290). 


§ 10437. 


Suspension of Effective Application 




(26290.5). 


§ 10438. 


Untrue Statements in Applications 




(26290) (e) and 26290.5 (2). 


§ 10440. 


Exemptions from Section 26670. 


§ 10445. 


Exemptions from Section 26288 of 




the Code (26292 (2) (3)). 


§ 10446. 


Exemptions for Dental 




Laboratories. 


§ 10450. 


Form of Guaranty (26297). 


§ 10455. 


Expiration of Guaranty (26301). 


§ 10460. 


Presentation (26341). 


icle 3. 


Food Regulations 132 


§ 10750. 


Label Requirements for Foods and 




Dietary Supplements. 


§ 10755. 


Truth of Labeling (26456). 


§ 10760. 


Metal Coated Dragees and 




Ornaments (26470 (2)). 


§ 10765. 


Toxic Substances — Use of (26470 




(2)). 


§ 10770. 


Secondhand Use of Barrels. 


§ 10775. 


Custard Fillings for Pastry (26470 




(4)). 


§ 10780. 


Containers, Cadmium Plated (26470 




(6)). 


§ 10785. 


Packing Materials (26470 (6)). 


§ 10786. 


Apricot Kernels. 


§ 10790. 


Candy, Trinkets in. Prohibited 




(26472 (b)). 


§ 10795. 


Blending and Dilution of Certified 




Coal Tai- Colors (26472 (c)). 


§ 10800. 


Labeling. Misbranding (26490 (1)). 


§ 10805. 


Required Statements, When Exempt 




(26491). 


§ 10810. 


Prominence of Required Statements 




(26492). 


§ 10815. 


Prepackaged Candy and Cookies, 




Retail Sale of Food from Bulk 




Containers (Label Exemptions) 




(26492). 


§ 10820. 


Exemption upon Proper Labeling. 


§ 10825. 


Conformity to Definitions and 




Standards of Identity (26493). 


§ 10826. 


Temporal^ Permits for Intrastate 




Shipment of Experimental Packs of 




Food Varying from the 




Requirements of Definitions and 




Standards of Identity. 


§ 10830. 


Designation of Ingredients (26495). 


§ 10835. 


Listing Ingredients in Order of 




Predominance (26495 (2)). 


§ 10840. 


Dietary Food Labeling (26496 (1)). 


§ 10841. 


Label Statements Relating to 




Emergency Food Packs. 


§ 10842. 


Saccharin Warning Labeling. 


§ 10845. 


Artificial Flavoring or Coloring, 




Chemical Preservatives (26496 (2)). 


§ 10850. 


Form of (Guaranty (26521). 


§ 10855. 


Expiration of Guaranty (26525). 


§ 10860. 


Exemptions from Labeling 




Requirements (26542). 


§ 10862. 


Adoption of Federal Requirements. 


§ 10865. 


Presentation (26565). 



Article 3.1. 


Food Additives Regulations .... 


. . 134 


Article 3.5. 


Foods Under Agricultural 






Code Regulations 


. . 134 


Article 3.6. 


Poultry Meat and Poultry 






Products 


. . 134 


§11375. 


Sources of Poultry Meat . 




§ 11376. 


Conditions for Use. 




§ 11377. 


Methods for Treating. 




§ 11378. 


Disposal of Unfit Poultry Meats. 




Article 3.7. 


Raw Milk and Raw Milk 






Products 


134.1 


§ 11380. 


Required Health Warning on Labels 
of Raw Milk and Raw Milk 
Products. 




Article 4. 


Horse Meat Regulations 


134.1 


Article 5. 


Cold Storage Regulations 


134.1 


§ 11600. 


Cold Storage Regulations. 




§11601. 


Cold Storage Licenses. 




Article 5.5. 


Low Acid Frozen Foods in 
Hermetically Sealed 






Containers, Regulations 


134.1 


Article 6. 


Bakery Sanitary Regulations . . . 


134.1 


§ 12001. 


Custard and Cream Fillings for 
Pastry (28208). 




Article 6. 1 . 


Local Enforcement of the 
Sherman Food, Drug and 
Cosmetic Law As It Relates 
to Retail Food 






Establishments 


. . 135 


§ 12100. 


Definitions. 




§ 12101. 


Application for Participation. 




§ 12102. 


Local Enforcement Authorization. 




§ 12103. 


Laboratory Examinations. 




§ 12104. 


Personnel Training. 




§ 12105. 


Staff Qualificadons. 




§ 12106. 


Reporting Requirements. 




§ 12107. 


Enforcement Authority for Menu 
Misrepresentation. 




§ 12108. 


Personnel Training. 




§ 12109. 


Staff Qualifications. 




§12110. 


Reporting Requirements. 




Article 7. 


Food Sanitation Regulations . . . 


.. 136 


§ 12200. 


Vegetable Juice, Preparation and 
Sale of Fresh (28281-28282). 




§ 12205. 


Premises. 




§ 12210. 


Materials. 




§ 12215. 


Extracting Machines. 




§ 12220. 


Storage and Sale. 




§ 12225. 


Employees. 




§ 12230. 


Revocation of Permit. 




§ T 17- 12235 


'<. Light, Ventilation, and Plumbing 
(28281). 




§ 12240. 


Water Supply. 




§ T17-1224f 


i. General Plant Sanitation: Floors, 
Walls, Ceilings, Etc. 




§ 12250. 


Areas. Equipment, and Operations 
to Be Sanitary. 




§ 12255. 


Use of Poisonous Insecticides and 
Rodenticides. 




§ 12260. 


Empty Container Storage. 




§ 12265. 


Bactericidal Treatment of Utensils 
and Equipment in Food Processing 
Establishments (28282(c)). 




§ 12270. 


Tagging Insanitary Equipment. 




§ 12275. 


Personal Hygiene. 




§ 12280. 


Sanitary Facilities. 




§ 12285. 


Surroundings of Food Packing 
Establishments (28298). 





Page xiv 



(7-25-2008) 



Title 17 



State Department of Health Services 



Table of Contents 



Page 



Page 



• 



^ 12290. 


Labeling Exemption (28322). 


§ 12295. 


Form of Affidavit. 


§ 12300. 


Purchase of Walnut Meats from 




Producers, Etc. (28336). 


§ 12302. 


Walnut Shelling Licenses. 


S 12305. 


Production Record Specifications. 


§ 12310. 


Bill of Sale Specification. 


§ 12315. 


Condition of Walnut Meats. 


icle 8. 


Cannery Inspection 




Regulations 


§ 12400. 


Applicability. 


§ 12405. 


Acid Requirements. 


§ 12410. 


Titration by Inspectors. 


§ 12415. 


Low Acid Ingi-edients in Acid 




Foods. 


§ 12420. 


Formulated Products. 


§ 12425. 


Test Equipment. 


§ 12430. 


Samples to Laboratory. 


§ 12435. 


Production Records. 


§ 12440. 


Inspectors' Reports. 


§ 12445. 


Releases. 


§ 12450. 


Responsibility of Canners. 


§ 12451. 


Cannery Licenses. 


§ 12455. 


Official Sterilization Processes. 


§ 12460. 


Initial Temperature. 


§ 12465. 


Cleanliness of Materials. 


§ 12470. 


Record of Cooks. 


§ 12475. 


Coding. 


§ 12480. 


Requirements. 


§ 12481. 


Examination of Can Closures and 




Can Closure Machines. 


§ 12482. 


Required and Optional Seam 




Measurements. 


§ 12485. 


Standards for Water Used in Fish 




Canneries. 


§ 12490. 


Establishments and Premises in or 



• 



§ 12495. 
§ 12500. 
§ 12505. 



§ 12510. 
§ 12515. 
§ 12520. 

§ 12525. 
§ 12530. 
§ 12535. 
§ 12540. 
§ 12545. 
§ 12550. 
§ 12555. 
§ 12560. 
§ 12565. 
§ 12570. 
§ 12575. 
§ 12580. 
§ 12585. 
§ 12590. 
§ 12595. 
§ 12600. 
§ 12605. 
§ 12610. 

§ 12615. 

§ 12620. 
§ 12625. 
§ 12630. 
§ 12635. 
« 12640. 



138 



on Which Food Products Are 

Prepared, Handled, Stored, or 

Packed Shall Be Maintained in a 

Sanitary Condition. 

Water Supply. 

Floors, Walls, Ceilings, Etc. 

Use of Poisonous Insecticides and 

Rodenticides in Food Processing 

Establishments. 

Animals in Plant. 

Sanitary Facilities. 

Areas. Equipment, and Operations 

to Be Sanitary. 

Personal Hygiene. 

Surroundings. 

Employment of Diseased Persons. 

Empty Container Storage. 

Tagging Insanitary Equipment. 

Recanning. 

Reporting Spoilage. 

Segregation. 

Examination. 

Monthly Reports. 

Sale to Salvage Company. 

Application. 

Venting of Canned Food Products. 

Tolerance per Batch. 

Supervision of Flip Testing. 

Segregation of Flip-Tested Cans. 

Holding After Flip Test. 

Cans Having Less Than 1 1/2" 

Internal Vacuum. 

Cans Having 1 1/2" or More 

Internal Vacuum. 

Normal Cans; No Spoilage. 

Normal Cans; Spoilage. 

Overfills and Hydrogen Swells. 

Sampling. 

Decision to Flip Test. 



§ 12645. 


Prevention of Salvage of Unfit 




Canned Foods. 


§ 12650. 


Applications. 


§ 12652. 


Exemption. 


§ 12655. 


General Rules. 


§ 12660. 


Standards for Inspection of Raw 




Fish. 


§ 12665. 


Inspection Service — Tuna. 


§ 12670. 


Raw Fish Reports. 


§ 12675. 


Fishing Vessels. 


§ 12680. 


Disposal of Condemned Fish. 


§ 12685. 


Sampling Canned Tuna. 


§ 12690. 


Horse Mackerel. 


§ 12695. 


Sanitary Boat Certificates. 


§ 12700. 


Supervision of Cleaning. 


§ 12705. 


Method of Cleaning. 


§ 12710. 


Application. 


§ 12715. 


Permission. 


§ 12720. 


Official Wording. 


§ 12725. 


Notification of Intention to Install 




Retorts. 


§ 12730. 


Obtaining Approval. 


§ 12735. 


Types of Retorts. 


§ 12740. 


Definition of Terms. 


§ 12745. 


Required Equipment for All Types 




of Retorts When Sterilizing Food in 




Tin or in Glass Jars with Closures 




Such That They May Be Processed 




in Steam. 


§ 12750. 


Additional Equipment Suggested 




but Not Required by the Department 




of Public Health. 


§ 12755. 


Venting of Retorts for Removal of 




Air, General Considerations. 


§ 12760. 


Venting of Horizontal Retorts for 




Removal of Air. 


§ 12765. 


Venting of Vertical Retorts for 




Removal of Air. 


§ 12767. 


Diagrams of Venting Systems. 


§ 12770. 


Notification of Intention to Install 




Retorts. 


§ 12775. 


Obtaining Approval. 


§ 12780. 


Equipment Required. 


§ 12785. 


Installation of Equipment. 


§ 12790. 


General. 


§ 12795. 


Animal Food Sterilization 




Processes. 


§ 12800. 


Asparagus Sterilization Processes. 


§ 12805. 


Beans, Dry: Sterilization Processes. 


§ 12810. 


Beans, Green and Wax, Whole or 




Cut: Sterilization Processes. 


§ 12815. 


Beans, Lima and Soy: Sterilization 




Processes. 


§ 12820. 


Bean Sprouts: Sterilization 




Processes. 


§ 12825. 


Beets: Sterilization Processes. 


§ 12830. 


Broccoli: Sterilization Processes. 


§ 12835. 


Brussels Sprouts: Sterilization 




Processes. 


§ 12840. 


Cabbage: Sterilization Processes. 


§ 12845. 


Carrots: Sterilization Processes. 


§ 12850. 


Carrot Juice: Sterilization 




Processes. 


§ 12855. 


Carrots and Peas: Sterilization 




Processes. 


§ 12860. 


Cauliflower: Sterilization Processes. 


§ 12865. 


Celery: Sterilization Processes. 


§ 12870. 


Chili Products: Sterilization 




Processes. 


§ 12875. 


Com: Sterilization Processes. 


§ 12880. 


Com Meal Mush: Sterilization 




Processes. 


§ 12885. 


Fish Products: Sterilization 




Processes. 


§ 12890. 


Hominy: Sterilization Processes. 



Page XV 



(7 2^ 2i)im 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Page 



§ 12895. 

§ 12900. 
§ 12905. 

§ 12910, 
§ 12915. 
§ 12920. 
§ 12925. 
§ 12930. 

§ 12935. 

§ 12940. 
§ 12945. 
§ 12950. 
§ 12955. 

§ 12960. 

§ 12965. 

§ 12970. 

§ 12975. 



Lentils in Unthickened Sauce: 

Sterilization Processes. 

Mushrooms: Sterilization Processes. 

Mushroom Sauce — Spaghetti Sauce: 

Sterilization Processes. 

Olives: Sterilization Processes. 

Parsnips: Sterilization Processes. 

Peas: Sterilization Processes. 

Potatoes: Sterilization Processes. 

Potatoes, Sweet: Sterilization 

Processes. 

Poultry Meat — Turkey: Sterilization 

Processes. 

Pumpkin: Sterilization Processes. 

Ravioli: SteriUzation Processes. 

Spaghetti: Sterilization Processes. 

Spinach, Packing and Sterilization 

Processes. 

Tamales, Cup: Sterilization 

Processes. 

Vegetables, Chopped: Sterilization 

Processes. 

Vegetables for Salad: Sterilization 

Processes. 

Vegetables, Strained: Sterilization 

Processes. 



§ 12976. 


Cookroom Personnel. 


§ 12977. 


Posting of Cooks 


§ 12978. 


Marking Containers. 


§ 12979. 


Time Limits. 


§ 12980. 


Double Door Retorts. 


§ 12981. 


Retort Markers. 


§ 12982. 


Care of Containers. 


§ 12983. 


Blanching. 


§ 12984. 


Posting Regulations. 


Article 9. 


Olive Oil Regulations 


§ 13500. 


Olive Oil Regulations. 


Article 10. 


Mobile Food Preparation 




Units 


§ 13600. 


Order Promulgating Standards. 


§ 13601. 


Definitions. 


§ 13602. 


Exterior Requirements. 


§ 13603. 


Interior Requirements. 


§ 13604. 


Temperature Requirements. 


§ 13605. 


Ventilation. 


§ 13606. 


Storage. 


§ 13607. 


Service Openings. 


§ 13608. 


Power Supply. 


§ 13609. 


Water Supply, Plumbing. 


Article 10.1. 


Commissaries Servicing 



152 



152 



Mobile Food Preparation 
Units 

§T17-13611. General Requirements . 

§13612. Waste Handling and Disposal. 

§ 13613. Water Supply and Plumbing. 

§ T17-13614. Electrical Hook-Up Facilities. 

§ T17-13615. Toilet and Lavatory. 

§ T17-13616. Facilities for Food Storage. 



155 



Article 10.2. 



§ 13620. 
§ 13621. 



Article 10.3. 



§ 13650. 



Requirements for the Sale of 
Imitation Hamburger in 
Restaurants 



155 



Definitions. 
Wallboard and Placard 
Requirements in Restaurants 
Without Menus. 

Requirements for Roadside 
Stands, Food Establishments 
Open to the Outside Air, 

and Retail Dairies 

Definitions. 



155 



Page 

§13651. Structural and Operational 

Requirements. 
§ 13652. Health Requirements. 

§ 13653. Enforcement and Inspection. 

Article 10.4. Ventilation Standards for 

Retail Food Establishments 156 

§ 1 3670. Adoption of the 1976 Uniform 

Mechanical Code. 
Building Plan Approval. 

Raw Oysters 1 56 

Raw Gulf Oysters: Labeling, 
Written Warnings and Additional 
Requirements. 
Request for Verification. 

Frozen Food Locker 

Regulations 156.3 

Frozen Food Locker Regulations. 

Licenses for Frozen Food Locker 

Plants. 

Hazardous Substances 

Regulations 157 

Definitions and Standards 157 

Food Standards 157 

Order Promulgating Standards. 

General Regulations. 

Examinations and 

Investigations — Samples. 

General Methods for Water Capacity 

and Fill of Containers. 

General Statements of Substandard 

Quality and Substandard Fill of 

Container. 

Flour and Cereal 

Products 157 

Corn Flour and Related 

Products 157 

Rice and Related 

Products 157 

Bakery and Bakery 

Products 157 

Alimentary Pastes 157 

Macaroni Products: Identity; Label 
Statement of Optional Ingredients. 
Enriched Macaroni Products: 
Identity; Label Statement of 
Optional Ingredients. 
Milk Macaroni Products: Identity; 
Label Statement of Optional 
Ingredients. 

Whole Wheat Macaroni Products: 
Identity; Label Statement of 
Optional Ingredients. 
Wheat and Soy Macaroni Products: 
Identity; Label Statement of 
Optional Ingredients. 
Vegetable Macaroni Products: 
Identity; Label Statement of 
Optional Ingredients. 
Noodle Products: Identity; Label 
Statement of Optional Ingredients. 
Enriched Noodle Products: Identity; 
Label Statement of Optional 
Ingredients. 
§ 15445. Wheat and Soy Noodle Products: 

Identity; Label Statement of 
Optional Ingredients. 



§ 13671. 


Article 10.5. 


§ 13675. 


§ 13676. 


Article 11. 


§ 13700. 
§ 13701. 


Article 12. 


Group 2. 


Article 13. 


§ 15200. 
§ 15205. 
§ 15210. 


§ 15215. 


§ 15220. 


Subarticle 1. 


Subarticle 2. 


Subarticle 2A, 


Subarticle 3. 


Subarticle 4. 


§ 15405. 


§ 15410. 


§ 15415. 


§ 15420. 


§ 15425. 


§ 15430. 


§ 15435. 


§ 15440. 



• 



Page xvi 



(7-25-2008) 



Title 17 



State Department of Health Services 



Table of Contents 



Page 



Page 



• 



§ 15450. Vegetable Noodle Products: 

Identity; Label Statement of 
Optional Ingredients. 

§ 15455. Oriental Style Noodles, Chinese 

Style Noodles, Japanese Style 
Noodles, Korean Style Noodles: 
Identity; Label Statement of 
Ingredients. 

§ 15460. Tagliarini: Identity; Label Statement 

of Optional Ingredients. 

§ 15465. Use of Secondhand Boxes for 

Alimentary Pastes. 

Subarticle 1 . Canned Vegetables 158 

Subarticle 2. Canned Vegetable Other 
Than Those Specifically 
Regulated 158 

Subarticle 3. Canned Tomatoes 158 

Subarticle 4. Tomato Products 158 

Subarticle 5. Tomato Products, Mold 

Filament Tolerance 158 

§ 15575. Tomato Catsup, Puree, and Paste. 

§ 15580. Tomato Juice. 

§15585. Comminuted Tomato Products. 

Subarticle 1 . Canned Fruit 158 

Subarticle 2. Fruit Preserves and 

Jellies 158 

Subarticle 3. Fruit Butters 158 

Subarticle 3.5. Citrus Products 158 

Subarticle 4. Carbonated Beverages 158 

Subarticle 1 . Dressings for Salads 159 

Subarticle 1 . Canned Shrimp 159 

Subarticle 2. Canned Oysters 159 

Subarticle 3. Raw Oysters 159 

Subarticle 4. Sea Food Cocktails 159 

§ 15825. Sea Food Cocktails. 

Subarticle 5. Canned Tuna Fish 159 

§ 15830. Eggs. 

§ 15835. Liquid Eggs, Mixed Eggs, Liquid 

Whole Eggs, Mixed Whole Eggs: 

Identity. 
§ 15840. Frozen Eggs, Frozen Whole Eggs, 

Frozen Mixed Eggs: Identity. 
§ 15845. Dried Eggs, Dried Whole Eggs; 

Identity. 
§ 15850. Egg Yolks, Liquid Egg Yolks, Yolks, 

Liquid YoUcs: 
§ 15855. Frozen Yolks, Frozen Egg Yolks: 

Identity. 
§ 15856. Egg Whites, Liquid Egg Whites, 

Liquid Egg Albumen; Identity. 
§ 15857. Frozen Egg Whites, Frozen Egg 

Albumen; Identity. 
§ 15860. Dried Egg Yolks, Dried Yolks; 

Identity. 
§ 1 586 1 . Dried Egg Whites, Egg White 

Solids, Dried Egg Albumen, Egg 

Albumen Solids; Identity. 
§ 15865. Cacao Nibs, Cocoa Nibs, Cracked 

Cocoa: Identity; Label Statement of 

Optional Ingi'edients. 



§ 15870. 


Chocolate Liquor, Chocolate, 




Baking Chocolate, Bitter Chocolate, 




Cooking Chocolate, Chocolate 




Coating, Bitter Chocolate Coating; 




Identity: Label Statement of 




Optional Ingredients. 


§ 15875. 


Breakfast Cocoa, High Fat Cocoa: 




Identity; Label Statement of 




Optional Ingredients. 


§ 15880. 


Cocoa, Medium Fat Cocoa: Identity; 




Label Statement of Optional 




Ingredients. 


§ 15885. 


Low-Fat Cocoa: Identity; Label 




Statement of Optional Ingredients. 


§ 15890. 


Sweet Chocolate, Sweet Chocolate 




Coating: Identity; Label Statement 




of Optional Ingredients. 


§ 15895. 


Milk Chocolate, Sweet Milk 




Chocolate, Milk Chocolate Coating, 




Sweet Milk Chocolate Coating: 




Identity; Label Statement of 




Optional Ingredients. 


§ 15900. 


Skim Milk Chocolate, Sweet Skim 




Milk Chocolate, Skim Milk 




Chocolate Coating, Sweet Skim 




Milk Chocolate Coating: Identity; 




Label Statement of Optional 




Ingredients. 


§ 15905. 


Buttermilk Chocolate, Buttermilk 




Chocolate Coating: Identity; Label 




Statement of Optional Ingredients. 


§ 15910. 


Mixed Dairy Product Chocolate, 




Mixed Dairy Product Chocolate 




Coating: Identity; Label Statement 




of Optional Ingredients. 


§ 15915. 


Sweet Chocolate and Vegetable Fat 




(Other Than Cacao Fat) Coatings: 




Identity; Label Statement of 




Optional Ingredients. 


§ 15920. 


Sweet Cocoa and Vegetable Fat 




(Other Than Cacao Fat) Coatings: 




Identity; Label Statement of 




Optional Ingredients. 


§ 15925. 


Distinction Between "Extract" and 




"Flavor." 


Subarticle 1. 


Extracts 160 


Subarticle 2. 


Flavors 160 


Subarticle 3. 


Labeling 160 


§ 15975. 


Labeling Defined. 


§ 15980. 


Where Label Statements Must 




Appear. 


§ 15985. 


Name and Address of Manufacturer 




or Distributor. 


§ 15990. 


Quantity of Contents Statement. 


§ 15995. 


Listing of Ingredients. 


§ 16000. 


Artificial Coloring. 


§ 16005. 


Artificial Flavoring. 


§ 16010. 


Chemical Preservatives. 


§ 16015. 


Guaranty Statements. 


§ 16020. 


Misleading Containers. 


§ 16025. 


Definitions. 


§ 16030. 


Sirup. 


§ 16035. 


Sugar-Cane Sirup. 


§ 16040. 


Sorghum Sirup. 


§ 16045. 


Maple Sirup. 


§ 16050. 


Sugar Sirup. 


§ 16055. 


Imitation Sirups. 


§ 16060. 


Labeling of Sirups. 


§ 16065. 


Vinegar, Cider Vinegar, Apple 




Vinegar. 


§ 16070. 


Distilled Vinegar, Spirit Vinegar, 




Grain Vinegar. 


§ 16075. 


Wine Vinegar, Grape Vinegar. 


§ 16080. 


Malt Vinegar, Beer Vinegar. 


§ 16085. 


Spices. 



Page xvii 



(7 2S 2()()S) 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



§ 16090. 
§ 16095. 
§ 16100. 


Subarticle 1, 


§ 16105. 


§ 16110. 


Subarticle 2 


§ 16112. 
§ 16113. 


Article 13.1. 


§ 16200. 
§ 16201. 


Article 14. 


§ 17000. 


§ 17001. 


§ 17005. 


§ 17010. 


§ 17015. 


§ 17075. 
§ 17076. 
§ 17090. 
§ 17100. 
§ 17105. 
§17116. 


Article 15. 


§ 18000. 


Article 16. 


§ 19000. 
§ 19001. 
§ 19005. 
§ 19010. 
§ 19015. 
§ 19020. 
§ 19025. 
§ 19030. 
§ 19035. 


§ 19040. 


§ 19041. 
§ 19043. 


Subchapter 3. 


Group 1. 



Group 2. 



Article 1. 



30001. 



Page 

Labeling of Vinegai^s. 
Adulteration. 
Imitation Vinegar. 

Olives, Ripe, Sold in 

Bulk 161 

Manner of Holding Bulk Ripe 

Olives. 

Label Stipulations of Bulk Ripe 

Olives. 

Canned Whole and Pitted 

Ripe Olives 161 

Definitions. 

Labeling. 

Actionable Defect Levels for 
Processed Foods 163 

General Provisions. 

Heat Processed Canned Peaches: 

Actionable Defect Levels for 

Insects. 

Wine Standards and 

Prohibited Practices 163 

Order Promulgating Regulations 

and Standards. 

Adoption and Application of 

Regulations and Standards. 

Standards of Identity and Quality for 

Wine Produced in California or 

Elsewhere. 

Provisions Applicable to Wine 

Produced in California. 

Wines Bearing the Appellation of 

Origin "California" or a 

Geographical Subdivision Thereof. 

Labeling. 

Combination Wines. 

Advertising of Wine. 

Sanitation. 

Enforcement. 

Constitutionality. 

Distilled Spirits Standards 164 

California Brandy. 

Processed Pet Food 

Regulations 165 

Order Promulgating Standards. 

Intent of Regulations. 

Definitions. 

Chemical Analysis. 

Exemptions. 

Required Verifications. 

Labeling and Restrictions. 

Manufacturing Requirements. 

Magnet to Remove Ferrous 

Material. 

Arsenic and Lead Tolerance in 

Animal Food. 

Pet Food Licenses and Certificates. 

Sources of Poultry Meat. 

Vector Control 167 

Standards Governing State Aid 

to Local Moscjuilo Control 

Agencies 167 

Standards Governing 

Certification of Local Vector 

Control Agency Personnel 167 

Definitions 167 

Certified Technician. 



§ 30003. 
§ 30005. 
§ 30007. 
§ 30009. 
§30011. 
§ 30013. 
§ 30015. 
§ 30017. 
§ 30019. 
§ 30054. 

Article 2. 

§ 30055. 
§ 30056. 
§30056.! 
§ 30056.: 
§ 30056.; 
§ 30056.- 



§ 30056 
§ 30057 
§ 30058 
§ 30059 

Article 3. 

§ 30061 

Subchapter 3.1. 



Article 1. 

§ 30062. 

Article 2. 



§ 30064. 
Article 3. 



§ 30066. 
Subchapter 3.2. 

Article 1. 

§ 30070. 
§30071. 

Article 2. 

§ 30072. 
§ 30073. 
§ 30073.1 

§ 30073.2 

§ 30074. 
§30074.1 

§ 30075. 

§ 30076. 
Article 3. 

§ 30077. 



Page 

Certified Technician (Limited). 

Continuing Education Unit. 

In-Service Training. 

Pesticide Label. 

Relevant Vectors. 

Under the Direct Supervision of. 

Vector. 

Vector Control Aide. 

Vector Control Agency. 

Definitions, 

Certification Examination 168 

Examination Requirements. 

Exainination Content. 

Interpretation of Dates. 

Applications. 

Admission to Examination, 

Notification of Examination 

Results. 

Processing Times. 

Expiration. 

Denial, Suspension, or Revocation. 

Records. 

Continuing Education 170 

Confinuing Education 
Requirements. 

Implementation of the 

Emergency Mosquito 

Abatement Funding Act of 

1983 170 

General Provisions 170 

Definitions. 
Conditions Governing 
Expenditure of the 
Emergency Mosquito 
Abatement Trust Account or 
Fund 171 

Application for Expenditure. 
Criteria for Determining If 
a Local Agency Has 
Established Adequate 
Emergency Mosquito 
Abatement Procedures 171 

Criteria for Emergency Mosquito 

Abatement Procedures. 

Importation of Wild 

Animals 171 

General 171 

Purpose and Scope. 
Definidons. 

Import Permits 171 

Wildlife Admitted by Permit, 
Application for Import Permits. 
Determination of Application 
Completeness and Notification, 
Application Time Periods for 
Processing a Permit Based on 
Actual Performance. 
Issuance of Import Permits. 
Importation of Animals Under 
Special Permit. 
Conditions of Quarantine for 
Personal Pets. 
Permit Fees. 

Quarantine Facilities and 

Operating Standards 174 

Animal Holding Facility. 



• 



Page 



XVllI 



(7-25-20 



Title 17 



State Department of Health Services 
Page 

Alternative Housing Facilities. Article 3. 
Primary Enclosures. S 30180 

Animal Health and Husbandry 

Standards. §30181. 

Approved Quarantine Facilities. ^ 3018'' 

Quarantine Provisions 174.1 Article 4. 

Quarantine. § 30190. 

Tuberculin Test. §30191 

Quarantine Records 174.2 ^ ^0192. 

Record Keeping. 

Animal Identification. (. -,^,f,^ , 

8 30192.1 

Quarantine Reporting 174.2 

Reporting of Tests Results, Physical § 30192.2 

Examinations, Illnesses, Deaths. 

§ 30192.3 
Cooperation with Other 

Governmental Agencies 174.2 §30192.4 

Cooperating Agencies. S lOig'' 5 

Exceptions 174.2 § 30192.6 

Exceptions. 
^ ,. . §30193. 

Radiation 175 

General .75 « ^''""'■ 

Definitions 175 ^3^,,^, 

General Dermitions. 

Registration Requirement. e 10194 ^ 

Communications. s 30195 ~ 

Exemptions and Enforcement 176 

Exemptions. §^0195.1 

Deliberate Misconduct. 

Registration of Sources of § 30195.2 

Radiation 176 

Registration Procedure 176 § 30195.3 

Registration Requirement. 

Initial Registration. 

Renewal of Registration. 

Registration Form. §30196. 

Separate Installations. = 30197. 

Report of Change. „ 

8 301 98 
Report of Discontinuance. s jui^o. 

Registration Shall Not Imply § ^^-O^- 

Approval. 

Vendor Obligation. 

Reportable Sources of Radiation. Article 5. 

Exclusions from § 30210. 

Registration 177 ^ 30210 "^ 

Excluded Material and Devices. 

Exempt Possessors. 

Records 177 

Radiation Protection Standards. 
Records to be Maintained. 
Violations. 

Article 6. 

^^^^ ^"^^ § 30220. 

Registration Fees. . 

Registration Fee, Mammography Article 7. 

Exception. 

Payment of Fee. 6 30225 

Licensing of Radioactive 
Materials 178 Article 8. 

^ 1 „ §30230. 

General 178 § 30231 

Authority. § 30232. 

License Requirement. Arf' 1 Q 

Communications. Article V. 

r^ .. . . § 30235. 

Deiimtions 179 § 30236. 

General Definitions. 



Table of Contents 



• 



§ 30077. 
§ 30078. 
§ 30079. 

§ 30080. 

Article 4. 

§30081. 
§30081. 

Article 5. 

§ 30082. 
§ 30083. 

Article 6. 

§ 30084. 

Article 7. 

§ 30085. 

Article 8. 

§ 30086. 

Subchapter 4. 
Group 1. 

Article 1. 

§ 30100. 
§ 30102. 
§ 30103. 

Article 2. 

§ 30104. 
§ 30105. 

Group 1.5. 



Article 1. 


§ 30108. 


§30110. 


§30111. 


§30112. 


§30113. 


§30115. 


§30116. 


§30117. 


§30118. 


§ 30120. 


Article 2. 


§ 30125. 


§ 30126. 


Article 3. 


§ 30130. 


§30131. 


§ 30140. 


Article 4. 


§ 30145. 


§ 30145.1 


§ 30146. 


Group 2. 


Article 1. 


§ 30170. 


§ 30172. 


§30173. 


Article 2. 


§ 30175. 



Page 

Exemptions 179 

Exempt Persons. Products, 
Concentrations and Quantities. 
Persons Exempt. 
Other Exemptions. 

Licenses 180 

Types of Licenses. 

General Licenses-Source Material. 

General Licenses — Static 

Elimination or Ion Generation 

Devices. 

General Licenses — Gauging and 

Controlling. 

General Licenses — Aircraft Safety 

Devices. 

General Licenses — Calibration or 

Reference Sources. 

General Licenses — Ice Detection 

Devices. 

General Licenses — In Vitro Testing. 

General Licenses — Depleted 

Uranium. 

Application for Specific Licenses 

and Amendments. 

Approval of Applications and 

Specific Terms and Conditions for 

Licenses. 

Criteria for Authorizing Multiple 

Locations of Use. 

Amendment Requests. 

Special Requirements for Issuance 

of Specific Licenses. 

Special Requirements for Issuance 

of Specific Licenses — Financial 

Surety for Decommissioning. 

Special Requirements for Issuance 

of Specific Licenses — Emergency 

Plans. 

Special Requirements for Issuance 

of Specific Licenses for Use of 

Sealed Sources in Industrial 

Radiography. 

Issuance of Specific Licenses. 

Specific Terms and Conditions of 

Licenses. 

Expiration of Licenses. 

Modification, Suspension, 

Revocation and Termination of 

Licenses. 

Transfer of Material I86 

Authorization for Transfer. 
Verification Required. 
Labeling Requirements for the 
Manufacture, Preparation or 
Transfer for Commercial 
Distribution of Drugs Containing 
Radioactive Material for Human 
Use as Authorized by a Specific 
License. 

Enforcement I86 

Violations. 

Reciprocal Recognition of 

Licenses 186 

Persons Licensed by Other 

Agencies. 

License Fees I86.1 

License Fees. 
Fee Schedule. 
Fee Limitations. 

Schedules 187 

Schedule A. Exempt Quantities. 
Schedule B, Table I, In Vitro 
Clinical Tests. 



Page xix 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



§ 30237. 
Group 3. 



Article 1. 

§ 30250. 
§30251. 
§ 30252. 
§ 30253. 



Article 2. 



Schedule C. 

Standards for Protection 
Against Radiation 



Page 



191 



§ 30254. 
§ 30255. 

§ 30256. 

§ 30257. 
§ 30258. 



Article 3. 



§ 30265. 
§30265.1. 
§ 30266. 



§ 30268. 

§ 30269. 

§ 30275. 
§ 30276. 
§ 30277. 
§ 30278. 
§ 30278.1. 

§ 30279. 



§ 30279.1 


§ 30280. 


§ 30281. 


§ 30282. 
§ 30285. 
§ 30287. 


§ 30288. 
§ 30289. 


Article 3.1. 


§ 30293. 
§ 30294. 


§ 30295. 
§ 30297. 


§ 30298. 
§ 30299. 


Article 4. 


§ 30305. 
§ 30306. 
§ 30307. 



General 191 

Authority. 

Purpose. 

Scope and Puipose. 

Standards for Protection Against 

Radiation. 

Notices, Instructions, and 

Reports to Workers; 

Inspections and 

Investigations 192 

Inspection. 

Notices, Instructions, and Reports to 

Personnel. 

Vacating Installations: Records and 

Notice. 

Bankruptcy Notification. 

General Definitions. 

Surveys and Tests 195 

Occupational Dose Limits. 

Determination of Prior Dose. 

Exposure of Individuals to 

Concentrations of Radioactive 

Material in Controlled Areas. 

Permissible Levels of Radiation in 

Uncontrolled Areas. 

Concentrations in Effluents to 

Uncontrolled Areas. 

Surveys and Tests. 

Personnel Monitoring. 

Bio- Assays and Medical Review. 

Caution Signs and Labels. 

Removal of Caution Labels from 

Empty Containers. 

Special Requirements for High 

Radiation Areas and Radiation 

Machines Capable of Producing 

High Radiation Areas. 

Additional Special Requirements for 

Very High Radiation Areas. 

Notices, Instructions, and Reports to 

Personnel. 

Storage and Control of Radioactive 

Material. 

Procedures for Opening Packages. 

General Requirement. 

Disposal by Release into Sanitary 

Sewerage Systems. 

Disposal by Burial in Soil. 

Treatment or Disposal by 

Incineration. 

Records and Notification 196.1 

Records. 

Reports of Theft or Loss of Sources 

of Radiation. 

Notification of Incidents. 

Reports of Overexposures and 

Excessive Levels and 

Concentrations. 

Vacating Installations. 

Bankruptcy Notification. 

Special Requirements for the 
Use of X-Ray in the Healing 
Arts 197 

General Provisions. 

Definitions. 

Fluoroscopic Installations 



Page 

§ 30308. Radiographic Installations (Other 

Than Dental and Veterinary 

Medicine). 
§ 30309. Special Requirements for Mobile 

Radiographic Equipment. 
§ 30310. Special Requirements for Chest 

Photofluorographic Installations. 
§ 30311. Dental Radiographic Installations. 

§ 30312. Therapeutic X-Ray Installations. 

§ 30313. Special Requirements for X-Ray 

Therapy Equipment Operated at 

Potentials of 50 kV and Below. 
§ 30314. Veterinary Medicine Radiographic 

Installations. 

Article 4.5. Requirements for the Use of 

X-Ray in Mammography 202.1 

§30315.10. Definitions. 

§ 30315.20. Facility Accreditation Certificate 

and Interim Facility Accreditation 

Certificate. 
§ 30315.22. Ehgibihty for a Facility 

Accreditation Certificate. 
§ 30315.23. Renewal of a Facility Accreditation 

Certificate. 
§ 30315.24. Interim Facility Accreditation 

Certificate. 
§ 30315.33. Complete Facility Application. 

§ 30315.34. Application Processing Times. 

§30315.35. Clinical Image Review. 

§30315.36. Mammography Review. 

§30315.50. Interpreting Physician 

Requirements. 
§ 30315.51. Personnel Requirements for 

Individuals Who Perform 

Mammography. 
§ 30315.52. Medical Physicist Requirements. 

§ 30315.60. Authorization and Renewal of 

Authorization to Conduct 

Mammography Surveys, Revocation 

and Suspension of Authorization 

and Application Processing Times. 
§30316. Mammography System 

Requirements. 
§ 303 16.10. Evaluations of New, Replaced or 

Repaired Equipment. 
§ 30316.20. Quality Assurance Testing. 

§ 30316.22. Acceptable Phantoms. 

§ 30316.30. Phantom Image Scoring Protocol. 

§ 30316.40. Processing of Mammogiams and 

Phantom Images. 
§ 30316.50. Mammographic Image 

Identification. 
§ 30316.60. Medical Physicist Survey Reports. 

§ 30316.61 . Instruments Used by Medical 

Physicists. 
§ 30317. General Facility Requirements. 

§ 30317.10. Mammography Quality Assurance 

Program. 
§ 30317.20. Quality Assurance Manual. 

§ 303 17.30. Mammography Procedures Manual . 

§ 30317.40. Maimnographic Examination 

Reports. 
§ 30317.50. Mammogi^am and Report Retention. 

§ 30317.60. Manmiography Medical Outcomes 

Audit. 
§30317.70. Consumer Complaints. 

§ 30318.10. Additional Requirements for Mobile 

Service Providers. 
§ 30318.11. Posting Requirements for Mobile 

Service Providers. 
§ 30319. Notification Requirements. 

§ 30319.20. Record Keeping Requirements. 

§ 30320.90. Grounds for Suspension, 

Revocation, Amendment or 

Restriction of a Facility 

Accreditation Certificate. 



• 



Page XX 



(7-25-2008) 



Title 17 



State Department of Health Services 



Table of Contents 



Article 5. 



Page 



203 



§30321. 

§ 30321.1. 
§ 30322. 



Article 6. 



§ 30330. 
§30331. 

§ 30332. 

§30332.1. 

§ 30332.2. 

§ 30332.3. 
§ 30332.4. 

§ 30332.5. 

§ 30332.6. 
§ 30332.7. 



§ 30332.8. 
§ 30333. 



§ 30333.05. 

§ 30333.07. 

§30333.1. 

§ 30333.2. 
§ 30333.3. 

§ 30334. 

§ 30335. 

§30335.1. 

§ 30335.2. 

§ 30335.3. 
§ 30335.4. 

§ 30335.5. 

§ 30335.6. 

§ 30335.10. 

§ 30336. 

§30336.1. 

§ 30336.5. 



Special Requirements for the 
Use of Radioactive Material 
in the Healing Arts 

Accountability, Storage, and 

Transit. 

Confirming Removal of Implants. 

Records and Reports of 

Misadministration. 



Special Requirements for 
Radiographic Operations in 
Industrial Radiography 203 

Definitions Specific to Industrial 

Radiography. 

Eligibility for and Renewal of 

Approval as a Radiation Safety 

Training Provider and Provider 

Requirements. 

Performance Requirements for 

Radiographic Exposure Devices, 

Storage Containers, and Source 

Changers. 

Security of Radiographic Exposure 

Devices, Storage Containers and 

Source Changers. 

Security of Permanent Radiographic 

Installations. 

Radiation Survey Instruments. 

Leak Testing, Repair, Tagging, 

Opening, Modification, and 

Replacement of Sealed Sources and 

Depleted Uranium Shielding. 

Quarterly Inventory of Sealed 

Sources. 

Utilization Logs. 

Inspection and Maintenance of 

Radiographic Exposure Devices, 

Storage Containers, Source 

Changers and Survey Instruments. 

Reporting Requirements. 

Training and Supervision for 

Radiographers and Radiographer's 

Assistants Using Sealed Sources. 

Radioactive Materials Radiographer 

Trainer Requirements. 

Radioactive Material Radiation 

Safety Officer Requirements. 

Operating and Emergency 

Procedures. 

Personnel Monitoring Control. 

Location of Documents and 

Records. 

Precautionary Procedures in 

Radiographic Operations Using 

Sealed Sources. 

Minimum Subjects to Be Covered in 

Training Radiographers. [Repealed] 

Radiographer Certification 

Categories. 

Eligibility for and Renewal of a 

Radiographer Certificate. 

Reciprocal Recognition. 

Provisional Radiographer 

Certificates. 

Complete Radiographer Certificate 

Application. 

Notification of Change of Name or 

Address. 

Radiation Safety Training 

Curriculum. 

Requirements for Shielded-Room 

Radiography. 

Requirements for Field 

Radiography. 

Requirements for Radiation 

Machine Radiographer's Assistants. 



§ 30336.6. 
§ 30336.7. 
§ 30336.8. 
§ 30337. 
§ 30338. 



Article 7. 



§ 30345.1. 
§ 30345.2. 
§ 30345.3. 
§ 30346. 

§ 30346.1. 
§ 30346.2. 
§ 30346.3. 
§ 30346.4. 
§ 30346.5. 
§ 30346.6. 

§ 30346.7. 

§ 30346.8. 
§ 30346.9. 
§ 30346.10. 
§30346.11. 

§30346.12. 

§30348.1. 
§ 30348.2. 

§ 30348.3. 
§ 30348.4. 
§ 30348.5. 
§ 30350. 
§ 30350.1. 

§ 30350.2. 

§ 30350.3. 



§ 30353. 
§ 30355. 



§ 30356. 
§ 30357. 

§ 30358. 



Group 4. 



Article 1. 


§ 30373. 


Group 5. 


§ 30385. 
§ 30390. 



Page 

Radiation Machine Radiographer 
Trainer Requirements. 

Radiation Machine Radiation 
Safety Officer Requirements. 

Industrial Radiography 
Certification and Provider Fees. 
Requirements for Use of Cabinet 
X-ray Systems. 

Grounds for Suspension, 
Revocation, Amendment, or 
Restriction of Radiogi'apher 
Certificates and Radiation Safety 
Training Provider Approvals. 

Radiation Safety 

Requirements for Well 

Logging Operations 208.8 

Scope. 

Definifions. 

Specific License for Well Logging. 

Agreement with Well Owner or 

Operator. 

Labels, Security and Transportation. 

Radiation Detection Instruments. 

Leak Testing of Sealed Sources. 

Physical Inventory. 

Records of Material Use. 

Design and Performance Criteria for 

Sealed Sources. 

Inspection, Maintenance and 

Opening of a Source Holder. 

Subsurface Tracer Studies. 

Radioactive Markers. 

Uranium Sinker Bars. 

Use of Energy Compensation 

Sources. 

Use of Tridum Neutron Generator 

Target Sources. 

Training Requirements. 

Operating and Emergency 

Procedures. 

Personnel Monitoring. 

Radiation Surveys. 

Radioactive Contamination Control. 

Security. 

Documents and Records Required at 

Field Stations. 

Documents and Records Required at 

Temporary Jobsites. 

Notification of Incidents and Lost 

Sources; Abandonment Procedures 

for Irretrievable Sources. 

Particle Accelerators For Well 

Logging. 

Appendix A. Concentrations in Air 

and Water Above Natural 

Background. 

Appendix B. 

Form RH 2364— Notice to 

Employees. 

Form RH 2365— Current 

Occupational External Radiation 

Exposure. 

Transportation of Radioactive 

Material 214 

Requirements for 
Transportation of 

Radioactive Material 214 

Transportation Reguladons. 

Participation by Local Health 
Departments 215 

Authority. 

General Definitions. 



Page xxi 



(7 2.S 2()()S) 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Page 

Article 1. Local Health Departments 215 

§ 30393. Participalion in Control Program. 

§ 30394. Application for Participation. 

§ 30395. Contract Authorizing Participation. 

§ 30397. Terms of Participation. 

Subchapter 4.5. Radiologic Technology 233 



Group 1. 

Article 1. 

§ 30400. 
§ 30400.5. 

§ 30400.40. 
§ 30400.60. 
§ 30400.85. 
§ 30400.95. 
§30401. 
§30401.6. 

Article 2. 

§ 30402. 

Article 3. 



§ 30403. 

§ 30403.5. 
§ 30403.8. 

Article 4. 

§ 30404. 

Article 5. 

§ 30405. 

Article 6. 

§ 30406. 

Article 7. 

§ 30408. 

Article 8. 



§ 30410. 
§ 30410.2. 

Group 2. 

Article 1. 

§ 30420. 

Article 2. 

§30421. 
§ 30422. 

Article 3. 

§ 30423. 

Article 4. 



Administration 



Definitions 

Fluoroscopy. 

Approved Continuing Education 

Credit. 

Fluoroscopy. 

Mammographic Examination. 

Radiography. 

X-ray Bone Densitometry. 

Radiography. 

X-ray Bone Densitometry. 

Special Permits 

Special Permits. 

Requirements for Continuing 
Education Performance, and 
Renewal of Certificates and 
Permits 

Requirements for Continuing 
Education and Performance of 
Mammographic Examinations. 
Renewal Procedures. 
Recordkeeping Requirement. 

Display of Certificates and 

Permits 

Display. 

Deadlines 

Deadlines. 

Change of Name and Address 
Change of Name and Address. 

Fees 

Fees. 



233 
233 



233 



234 



234 



234 



235 



235 



Authorization to X-Ray 

Technicians to Perform 

Digital Radiography 235 

Authorization to X-Ray Technicians 

to Perform Digital Radiography. 

Instruction in Digital Radiologic 

Technology. 

Training of Students of 

Radiologic Technology 236 

General 236 

Application Procedure. 

Radiologic Technology 

Schools 236 

Diagnostic Radiologic Technology 

Schools. 

Therapeutic Radiologic Technology 

Schools. 

Radiologic Technologist 
Fluoroscopy Permit Schools 237 

Radiologic Technologist 

Fluoroscopy Permit Schools. 

Limited Peniiit X-Ray 

Technician Schools 238 



Page 

§ 30424. Limited Permit X-Ray Technician 

Schools Teaching the Chest, 
Extremities, Gastrointestinal, 
Genitourinary, Leg-Podiatric, Skull, 
or Torso-Skeletal Categories. 

§ 30425. Limited Permit X-Ray Technician 

Schools Teaching the Dental 
Laboratory Category. 

§ 30426. Photofluorographic Chest X-Ray 

Technician Courses of Study. 

§ 30427. Liinited Permit X-Ray Technician 

Schools Teaching the Dermatology 
X-Ray Therapy Category. 

§ 30427.2. Limited Permit X-Ray Technician 

Schools Teaching the X-Ray Bone 
Densitometry Category. 

Article 5. On-the-Job Training for X- 

Ray Technicians 239 

§ 30428. Approval of On-the-Job Training. 

Article 6. Notification 239 

§ 30435. Notification Requirements. 

Article 7. Disciplinary Action 239 

§ 30436. Standards for Suspension or 

Revocation of Approval. 

Article 8. Additional School 

Requirements and 

Recordkeeping 240 

§ 30437. Additional School Requirements 

and Recordkeeping. 

Group 3. Certificates for Radiologic 

Technologists and Permits for 

Limited Permit X-Ray 

Technicians 240 

Ai'ticle 1 . Certification of 

Technologists 240 

§ 30440. Issuance of Certificates. 

§30441. Acceptable Applications. 

Article 2. Permits for Limited Permit X- 

Ray Technicians 240 

§ 30442. Categories. 

§ 30443. Scopes. 

§ 30444. Issuance of Limited Permits. 

§ 30445. Acceptable Applications. 

§ 30445.1. Acceptable Applications: X-ray 

Bone Densitometry. 

§ 30446. Title. 

§ 30447. Restrictions. 

Group 4. Use of Fluoroscopy Equipment 

by Radiologic Technologists 240.1 

Article 1 . Radiologic Technologist 

Fluoroscopy Permits 240.1 

§ 30450. Permit Requirement. 

§ 30451. Issuance of Technologist 

Fluoroscopy Permits. 
§ 30452. Acceptable Applications. 

Group 4.5. Use of Mammography Equipment 

by Radiologic Technologists 240.2 

Article 1 . Mammographic Technology 

Certificates 240.2 

§ 30455. 1 . Issuance of a Mammographic 

Radiologic Technology Certificate. 

Group 5. Certification of Licentiates 240.2 

Article 1 . Licentiate Certificates and 

Permits 240.2 



Page xxii 



(7-25-2008) 



Title 17 



State Department of Health Services 



Table of Contents 



§ 30460. 
§30461. 
§ 30462. 
§ 30463. 
§ 30464. 
§ 30465. 
§ 30466. 

§ 30467. 

§ 30468. 
Group 7. 

Article 1 . 

§ 30470. 
§30471. 

Article 2. 

§ 30473. 

Article 3. 

§ 30475. 

Article 4. 

§ 30477. 

§ 30479. 

§30481. 
Article 5. 

§ 30483. 

Article 6. 

§ 30485. 

Article 7. 

§ 30487. 

§ 30489. 
§ 30491. 

Article 8. 



Page 

Licentiate Certificate. 

Licentiate Permits. 

Radiology Certificate. 

Fluoroscopy Permits. 

Radiography Permits. 

Dermatology Permits. 

Issuance of Licentiate Certificates or 

Permits. 

Certification of Qualified 

Licentiates. 

Acceptable Applications. 

Requirements for Land Disposal 

of Radioactive Waste 240.2(a) 

Applicable Federal 

Regulations 240.2(a) 

Low-Level Radioactive Waste 

Disposal. 

Transfer for Disposal, Manifests and 

Record Keeping. 



Article 2. 



Certification of Nuclear 
Medicine Technologists 



Page 



240.3 



General 

Definitions. 



240.2(a) 



§ 30520. 


Competency Criteria. 


§30521. 


Supervision Requirements. 


Article 3. 


Administration 240.4 


§ 30530. 


Acceptable Applications. 


§30531. 


Application Process and Deadlines. 


§ 30532. 


Issuance of Certificates. 


§ 30533. 


Scopes of Certificates. 


§ 30534. 


Title. 


§ 30535. 


Fees. 


§ 30536. 


Renewal Procedures. 


§ 30537. 


Notification Requirements. 


Article 4. 


Exemptions and Enforcement . . 240.5 


§ 30540. 


Students of Nuclear Medicine 




Technology. 


§30541. 


Special Permits. 


§ 30542. 


Display. 


§ 30543. 


Inspection. 


§ 30550. 


Fuel Tank Emissions. 


§ 30560. 


Carburetor Hot Soak Emissions. 


§ 30570. 


Exhaust Odor and Irritation. 



Proprietary Documents 240.2(a) 

Proprietary Documents. 
Selection of License 
Designee 240.2(a) 

Application for Selection as License 

Designee. 

Standards for Selecting the License 

Designee. 

Acceptance by License Designee. 

Forfeiture of Performance 

Bond 240.2(b) 

Standards for Forfeiture of the 

Performance Bond. 



Subchapter 5. Air Sanitation 241 

Article 1 . Standards for Ambient Air 

Quality 241 

§ 30690. Table of Standards and Explanatory 

Footnotes. 

Subchapter 6. Organized Camps 242 



Fees 

License Fee. 



240.2(b) 



Financial Assurances 240.2(b) 

Additional Licensee Requirements 
and Financial Assurances. 
Funding for Disposal Site Closure 
and Stabilization. 
Liability Insurance. 



Rate Review and Approval 

Process 240.2(c) 

§ 30493. Establishment and Approval of 

Rates. 
§ 30495. Calculation of the Rate Schedule. 

§ 30497. Rate Review Documentation. 

§ 30499. Adjustment of Rate Schedule. 

Subchapter 4.6. Nuclear Medicine 

Technology 240.2(c) 



Article 1. 

§ 30500. 

§30501. 
§ 30502. 
§ 30503. 
§ 30504. 
§ 30505. 
§ 30506. 
§ 30507. 

§ 30508. 
§ 30509. 

§ 30510. 



Definitions 240.2(c) 

Certified Technologist, Nuclear 

Medicine. 

Direct Supervision. 

General Supervision. 

In Vitro Test. 

In Vivo Test. 

Licensed Clinical Bioanalyst. 

Nuclear Medicine Physician. 

Nuclear Medicine Technology 

Procedures. 

Special Permit. 

Student of Nuclear Medicine 

Technology. 

Supervisor. 



Article 1. 


General 


. 242 


§ 30700. 


Definitions. 




§30701. 


Limitation of Scope. 




§ 30702. 


General Camp Safety 
Requirements. 




§ 30703. 


Notice of Intention to Operate. 




§ 30704. 


Requirements for Camps. 




Article 2. 


Utilities 


. 243 


§ 30710. 


Water Supply. 




§30711. 


Drinking Water. 




§30712. 


Handwashing Facilities. 




§30713. 


Showers. 




§ 30714. 


Toilets. 




§ 30715. 


Plumbing. [Repealed] 




Article 3. 


Housing 


. 243 


§ 30720. 


Building Structures. 




§30721. 


Sleeping Accommodations. 




§ 30722. 


Repair, Safety, Maintenance and 
Sanitation. 




§ 30723. 


Overhead Electrical Line 
Construction. 




§ 30724. 


Mechanical Installation. [Repealed] 




Article 4. 


Food Service Facilities and 






Operations 


. 244 


§ 30730. 


Food Service Facilities. 




§30731. 


Light, Ventilation and Sanitary 
Facilities. 




§ 30732. 


Cleaning and Sanitizing of Multiuse 
Utensils. 




§ 30733. 


Storage of Food, Utensils and 
Equipment. 




§ 30734. 


Health Requisites for Food Service 
Personnel. 




Article 4. 1 . 


Food Service Facilities and 





Operations at Intermittent 
Short-Term Organized Camps 
[Repealed] 



244 



Page xxiii 



Table of Contents 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Page 



Page 



§ 30734.1. Food Service Facilities and 

Operations at Intermittent 
Short-Term Organized Camps. 
[Repealed] 

Article 5. Solid Waste 244 

§ 30735. Garbage and Refuse. 

Article 6. Vector Control 244 

§ 30736. Vectors and Pests. 

Article 7. Swimming and Bathing 245 

§ 30740. Swimming Facilities. 

§ 30741 . Lake, Stream, River or Ocean 

Swimming. 

Article 8. Supervision 245 

§ .30750. Health Supervision. 

§ 30751. General and Safety Supervision. 

§ 30752. Firearms. 

§ 30753. Emergency Plan. 

Subchapter 7. Wiping Rags 246 

Article 1 . Definitions 246 

Article 2. Minimum Standards for 

Sanitizing 246 

§30801. Standards. 

Subchapter 8. Drinking Utensils and Ice 

Buckets 246 

Article 1. Definitions 246 

§ 30850. Single Service. 

§30851. Multiuse. 

Article 2. Washing, Sanitizing, and 
Handling of Drinking 
Utensils and Ice Buckets in 
Hotels, Motels, and Other 
Pubhc Places 246.1 

§ 30852. Utensils and Containers, Conditions 

of Use and Storage. 
§ 30853. Hand Dishwashing and Sanitizing. 

§ 30854. Sanitizing Solutions for Hand 

Dishwashing. 
§ 30855. Machine Washing and Sanitizing. 

§ 30856. Sanitizing Requirements for 

Dishwashing Machines. 
§ 30857. Maintenance and Construction 

Requirements. 
§ 30858. Inspection Authority. 



Chapter 6. 



Lead Poisoning Prevention 
Programs 



247 



icle 1. 


Definitions 


§33001. 


Applicant. 


§ 33002. 


Architectural Coating. 


§ 33003. 


Architectural Coating Distribution. 


§ 33004. 


Architectural Coating Distributor. 


§ 33005. 


Appurtenance. 


§ 33006. 


Business Entity. 


§ 33007. 


Department. 


§ 33008. 


Environmental Lead 




Contamination. 


§ 33009. 


Fee. 


§ 33010. 


Historically Associated. 


§33011. 


Industry. 


§ 33012. 


Motor Vehicle Fuel. 


§ 33013. 


Motor Vehicle Fuel Distribution. 


§ 33014. 


Motor Vehicle Fuel Distributor. 


§ 33015. 


Ongoing and Chronic Exposure. 



Article 2. 



Fees 



248.2 



§ 33020. Fees Attributable to Leaded 

Architectural Coatings. 
§ 33025. Fees Attributable to Leaded 

Gasoline. 
§ 33030. Fees Attributable to Facilities 

Releasing Lead into Ambient Air in 

California. 

Article 3. Exemption from Fees 248.3 

§ 33040. Exemption From Fees. 

Article 4. Application to Reassess Fee — 248.4 

§ 33050. Apphcation to Reassess Fee. 

Chapter 7. Health Facilities Planning 248.4 

Chapter 7.5. Eminent Domain Procedures for 

Nonprofit Hospitals 248.4 

Chapter 7.7. Fire Protection Loans 248.4 

Chapter 8. Accreditation, Certification and 
Work Practices for Lead-Based 
Paint and Lead Hazards 248.4 

Article 1. Definitions 248.4 

§35001. Abatement. 

§ 35002. Accreditation. 

§ 35003. Accredited Training Provider. 

§ 35004. CDPH-Approved Course. 

§ 35005. Certified Lead Inspector/Assessor. 

§ 35005. 1 . Certified Lead Project Designer. 

§ 35006. Certified Lead Project Monitor. 

§ 35007. Certified Lead Sampling 

Technician. 

§ 35008. Certified Lead Supervisor. 

§ 35009. Certified Lead Worker. 

§ 35010. Certificate. 

§35011. Guest Instructor. 

§ 35012. Certified Industrial Hygienist. 

§ 35013. Clearance Inspection. 

§ 35014. Component. 

§35015. Contact Hour. 

§ 35016. Containment. 

§ 35017. Job Tasks. 

§35018. Continuing Education. 

§ 35019. Course Completion Form. 

§ 35020. Demonstration Testing. 

§35021. Department. 

§ 35022. Deteriorated Lead-Based Paint. 

§ 35023. DHS-Approved Course. [Repealed] 

§ 35024. Photo Identification Number. 

§ 35025. Guest Instructor. 

§ 35026. Hands-on Training. 

§ 35027. Industrial Building. 

§ 35028. Instructor. 

§ 35029. Interactive/Participatory Teaching 

Methods. 

§ 35030. Interim Certificate. 

§35031. Job Tasks. 

§ 35032. Lead Activities. 

§ 35033. Lead-Based Paint. 

§ 35034. Lead Certification Examination. 

§ 35035. Lead-Contaminated Dust. 

§ 35036. Lead-Contaminated Soil. 

§ 35037. Lead Hazard. 

§ 35038. Lead Hazard Evaluation. 

§ 35039. Lead Inspection. 

§ 35040. Lead-Related Construction Work. 

§ 35041. Photo Identification Number. 

§ 35042. Postsecondary Education. 

§ 35043. Presumed Lead-Based Paint. 

§ 35044. Provisional Accreditation. 

§ 35045. Public Building. 

§ 35046. Residential Building. 

§ 35047. Risk Assessment. 

§ 35048. Train-the-Trainer Course. 



Page xxiv 



(7-25-2008) 



Title 17 



State Department of Health Services Table of Contents 

Page Page 

Training Director. Article 13. Eligibility Requirements and 

^"'''^ ^'^^- Application Procedures for 

Eligibility Requirements for Certification or Interim 

Accreditation and Course Certification 248.18(g) 

Approval 248.14 § 35081 . Representation of Certification 

Representation of Accreditation Status. 

Status. § 35082. Application Timeliness. 

Eligibility Requirements. § ^50^^- Inspector/Assessor. 

Personnel Requirements. § -''-''085. Supervisor. 

Operational Requirements. § ^-^087. Project Monitor. 

§ 35088. Project Designer. 

Core Instruction 248.16 § 35089. Sampling Technician. 

Core Instructional Requirements. § 35091. Worker. 

§ 35093. Interim Certification and Renewal. 

Lead-Related Construction § 35095. Application Requirements. 

Inspection and Assessment § -^-^O^^. Certification, Interim Certification. 

_ and Renewal Procedures. 

Course 248.16 

Course Requirements. Article 14. Suspension or Revocation ot 

Certification or Interim 

Lead-Related Construction /- .f .■ ^..,,0, 

Certification 248.i8(k) 

Supervision and Project ^ 33097 ^^^-^^ ^^ ^^^^^^^ ^^ r^^„^. 

Monitoring Course 248.17 Certification or Interim 

Course Requirements. Certification. 

Lead-Related Construction ^^i^le 15. Enforcement 248.18(1) 

Sampling Technician § ^^^^"^^ ^""^^'"2 ^^^^ Enforcement. 

(^Q^j-gg 748 18(a) Article 16. Work Practice Standards 248.18(1) 

Course Requirements. § ^^000. Requirements for Lead Hazard 

Evaluation for Public and 

Lead-Related Construction Residential Buildings. 

Work Course 248.18(a) f ,^^?^^- ^ead-Safe Work Practices. 

§36100. Requirements for Abatement for 

Course Requirements. Pubjjc .^^ Residential Buildings. 

Lead-Related Construction Chapter 9. Screening for Childhood Lead 

Supplemental Supervision Poisoning 248.18(n) 

and Project Monitoring 

Course 248.18(b) ^"i^^^ ^- Definitions 248.18(n) 

Course Requirements § ^"^^00. Health Care Provider. 

t^ourse Kequirements. ^ ^^^^^ Physician. 

Lead-Related Construction § 37010. Physician's Assistant. 

r tT AT A t ■ 1 §37015. Primary Medical Care. 

L^ertllied industrial ^ 3-7020. Publicly Funded Program for Low 

Hygienist Course 248.18(c) Income Children. 

Course Requirements. § 37025. Screening. 

Continuing Education 248.18(d) Article 2. Standard of Care on 

Continuing Education for Workers Screening for Childhood 

Requirements. Lead Poisoning 248.18(0) 

General Continuing Education §37100. Requirements. 
Requirements. 

Application Requirements and ^^^P^^^ ^ ^ • Occupational Lead Poisoning 

Procedures for Training Prevention Program 248.l8(o) 

Provider Accreditation, Article 1. Definitions 248.1 8(0) 

Renewal, or Course § 38001. Occupational Lead Poisoning 

» 1 ^..r, 10.JX Prevention Program: Definitions. 

Approval 248.18(d) ^ 

Application Requkements. Article 2. Waivers of the Occupational 

Accreditation Procedures. Lead Poisoning Fee 248.l8(p) 

Suspension or Revocation of f ^^002. Fee Waiver Eligibility. 

. . 8 38003. Procedures for Application of a 

Accreditation, Provisional Waiver. 

Accreditation, or DHS § 38004. Periods for Which Fee Waivers Are 

Course Approval 248.18(g) *^'''^^''''^- 

Action to Suspend or Revoke Article 3. Applicable Industries 248.19 

Accreditation, Provisional § 38005. Occupational Lead Poisoning Fee: 

Accreditation, or Course Approval. Applicable Industries. 



§ 35049. 
§ 35050. 



Article 2. 



§35051. 

§ 35052. 
§ 35053. 
§ 35054. 

Article 3. 

§ 35055. 
Article 4. 



§ 35056. 
Article 5. 

§ 35057. 

Article 6. 

§35061. 

Article 7. 

§ 35065. 
Article 8. 



§ 35066. 
Article 9. 

§ 35067. 

Article 10. 

§ 35070. 

§ 35072. 
Article 11. 



§ 35076. 
§ 35078. 

Article 12. 



§ 35080. 



Page XXV 



Title 17 



State Department of Health Services 



§103 



TITLE 17. PUBLIC HEALTH 



Division 1 . State Department of Health 
Services 

(Originally Printed 8-15-45) 



Chapter 1. Administration 



Subchapter 1. 



State Department of Health 
Services 



(Originally Printed 6-30-73) 

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: 
Chapter 1252, Statutes of 1977. 

History 

1 . New Subchapter 1 (Sections 1 through 4) filed 6-29-73 as an emergency; desig- 
nated effective 6-30-73 (Register 73, No. 26). 

2. Certificate of Compliance filed 10-24-73 (Register 73, No. 43). 

3. Amendment filed 6-30-78 as an emergency; designated effective at 1 1 :59 p.m. 
on 6-30-78 (Register 78, No. 26). 

4. Certificate ofCompliance transmitted to OAH 10-27-78; filed 10-31-78 (Reg- 
ister 78, No. 44). 

5. Repealer of Subchapter 1 (Sections 1-5) filed 9-27-85; effective thirtieth day 
thereafter (Register 85, No. 40). For prior history, see Register 78, No. 44; 78, 
No. 26; and 74, No. 41. 



Subchapter 2. Hospital Districts 



Article 1. Liability Loans 

§100. Eligibility Requirements. 

(a) Hospital districts may apply for State loans to pay for medical inju- 
ry tort claims or judgments that are in excess of $300,000. Such hospital 
districts shall meet all of the following: 

( 1 ) Be the Chowchilla Memorial Hospital District, or a hospital district 
which has entered into a joint powers agreement with the Chowchilla 
Memorial Hospital District. 

(2) Be located in a county that has areas that are designated as rural 
medically undeserved areas by the Health Manpower Policy Commis- 
sion, pursuant to Section 1 188.4, Chapter 4, Part 4, Health and Safety 
Code (Rural Health Services, October 1976). 

(3) Have a licensed bed capacity of less than 100 beds. 

(4) Have submitted to the Department on or before September 8, 1977, 
a statement which includes the following: 

(A) A utilization review plan or its equivalent which has been official- 
ly adopted by the governing body of the hospital districts and which: 

1 . Provides for the participation of the entire medical staff in a review 
committee. 

2. Provides that at least one committee member is a nonphysician 
health professional. 

3. Prohibits the participation on the committee of any person who has 
a financial interest in the hospital. 

4. Prohibits any person from participation in the review of any care in 
which that person has been professionally involved. 

5. Provides for at least monthly meetings of the review committee. 

6. Provides for the retention for at least seven years of records of the 
review committee's activities, including the number and types of cases 



received, the findings and recommendations, and the subsequent actions 
taken. 

(B) Proof of either insurance against medical injury liability claims or 
judgments up to $300,000 or the establishment of a reserve account in 
that amount, along with a plan for the investment of such reserves. 

(C) A written plan for the preliminary investigation of medical injury 
claims and for procurement of legal counsel when indicated. 

(D) A written plan to repay the State loan within forty (40) years detail- 
ing the resources available to the hospital district including taxing pow- 
ers. 

NOTE: Authority cited: Sections 32351-32355 and 32358, Health and Safety 
Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety 
Code. Division 23. 

History 

1. New Subchapter 2 (Sections 100-103) filed 12-6-79; effecdve thirtieth day 
thereafter (Register 79, No. 49). 

§101. Loan Application. 

(a) The hospital district shall make application for a State loan to the 
Director of Health Services, 714 P Street, Sacramento, CA 95814. 

(b) Within ninety (90) days after the receipt of the application the De- 
partment of Health Services will notify the applicant of its preliminary 
finding and recommendation. The notice will contain the information 
that the Department's final recommendation to the Legislature must be 
made within the next thirty (30) days and that any information that the 
applicant has that will affect the preliminary recommendation should be 
forwarded immediately. 

NOTE; Authority cited: Secfions 32351-32355 and 32358, Health and Safety 
Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety 
Code, Division 23. 

§102. Coverage. 

(a) The Department shall grant all loans which qualify, to the extent 
that funds are available, provided that: 

(1) Such amount represents an excess of $300,000 in a medical injury 
tort judgment or settlement, the $300,000 being covered by insurance or 
reserve account, as specified in Section 100(a)(4)(B). 

(2) The total amount of such loans does not exceed $1 ,000,000 in the 
aggregate. 

(b) Physicians in the local community who are employees of the hospi- 
tal district shall be covered for medical injury tort liability by the district. 

NOTE: Authority cited: Sections 32351-32355, Health and Safety Code, Division 
23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division 

23. 

§ 103. Repayment of Loans. 

(a) Repayment of loans shall be on an amortized schedule agreed upon 
by the Department and the hospital district. The repayment period shall 
not exceed forty (40) years. The interest rate shall not exceed the five- 
year average on the return on the investment of State funds pursuant to 
Chapter 3 (commencing with Secfion 16430), Part 2, Division 4, Title 2 
of the Government Code. 

(b) In event of default of repayment of a loan, the Department may at- 
tach real property and assets of the hospital district to recover the amount 
of the loan and appropriate interest as specified in (a) above. 

NOTE: Authority cited: Sections 32351-32355, Health and Safety Code. Division 
23. Reference: Sections 32351, 32353, 32355 and 32358, Health and Safety Code, 
Division 23. 

Subchapter 3. Hospital Inspection 

(Originally Printed 8-15-^5) 
Revision (except Group 1) filed 3-30-51 
Revision of Group 2 filed 1-19-54 and 6-13-75 
Revision of Group 1 filed 7-15-57 



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Title 17 



Group 1. Clinics and Dispensaries 

Note; Authority cited: Sections 1231 and 141 1, Health and Safety Code. 

History 

1. Subchapter 3 originally printed 8-15^5 (Title 17). 

2. Additions and amendments to Subchapter 3 jiled between 8-15-45 and 7-6-57 
published in Registers 5; 8; 10, No. 3; 11, No. 4: 12, No. 4; 12, No. 5; 12, No. 
6: 14, No. 1; 14, No. 6: 53, No. 9; 54, No. 2; 56, No. 10. 

3. Revision of Subchapter 3 (except Group 1 ) filed 3-30-5 1 ; effective thirtieth day 
thereafter (Register 23, No. 7). 

4. Revision of Subchapter 3, Group 1 (i.e. Repealer of §§ 161, 166, 171, 176. 181. 
186, and new §§ 161-167, 169-178. 180, 183, 186, 187. 190, 193, 194, 197, 
198, 201 , 204, 207-224) filed 7-1 5-57; effective thirtieth day thereafter (Regis- 
ter 57, No. 1 1 ). 

5. Repealer of Group 1 (Sections 161 through 198) filed 10-1 1-74; effective thir- 
tieth day thereafter (Register 74, No. 4 1 ). For prior history, see Registers 64, No. 
14; 71, No. 10;and72rNo. 16. 



Group 2. Health Facilities 

NOTE: Authority cited: Sections 102, 208 and ] 41 1, Health and Safety Code. Ref- 
erence: Sections 1400-1433, Div. 2, Chap. 2, Health and Safety Code. 

History 

1. New section filed 7-21-70 as an emergency: effective upon filing (Register 70, 
No. 30). 



2. Certificate of Compliance- 
ister 70, No. 47). 



-Section 1 1422.1, Gov. Code, filed 1 1-17-70 (Reg- 



3. Amendment filed 1-31-73 as an emergency: effective upon filing (Register 73, 

No. 5). 

4. Amendment filed 6-22-73 as an emergency; effective upon filing. Certificate 
of Compliance included (Register 73, No. 25). 

5. Repealer of Subgroup 1 and Subgroup 1 .5 (Sections 229 through 395.4, not con- 
secutive) of Group 2 filed 6-13-75; effecdve thirtieth day thereafter (Register 
75. No. 24). For prior history, see Registers 56, No. 10; 58, Nos. 10, 12; 59, No. 
12; 63, Nos. 14, 20; 64, Nos. 4, 10, 16, 22; 65, No. 1 1 ; 66,Nos. 8, 25, 34, 44; 67, 
Nos. 1 1, 50; 68, Nos. 14, 49; 69, Nos. 13, 19, 29, 39, 52; 70, Nos. 12, 30, 33,47; 
71, Nos. 10, 31, 48; 72, Nos. 16, 32, 44; 73, Nos. 5, 25; and 74, No. 18. 



Subgroup 2. Requirements for Outpatient 
Clinics 

NOTE: Authority cited: Secfions 102, 208 and 1411, Health and Safety Code. Ref- 
erence: Sections 1400-1433, Div. 2, Ch. 2, Health and Safety Code. 

History 

1 . New Subgroup 2 (Sections 400-488, not consecutive) filed 6-22-73 as an emer- 
gency; effective upon filing. Certificate of C'ompliance included (Register 73, 
No. 25). For history of former Subgroup 2, see Register 73, No. 14. 

2. Amendment filed 10-1 1-74; effective thirtieth day thereafter (Register 74, No. 
41). 

3. Amendment filed 1 1-12-76 as an emergency, effecdve upon filing (Register 
76, No. 46). 

4. Certificate of Compliance filed 3-8-77 (Register 77, No. 11). 

5. Repealer of Subgroup 2 (Sections 400-488, not consecuUve) filed 1-18-82; ef- 
fective thirtieth day thereafter (Register 82, No. 4). 



Group 3. Nonprofit Hospitals 

(Originally Printed 8-15-45) 
Note: Authority cited: Sections 11501, 1 1502, and 1 1503 of Insurance Code. 

History 
1 . Repealer of Group 3 (SecUon 850) filed 6-13 -75; effective thirtieth day thereaf- 
ter (Register 75, No. 24). 



Group 4. Establishments for Handicapped 
Persons 

NOTE: Authority cited for Secfions 860.0-875.0: Secfion 1509, Health and Safety 
Code. 

History 
1. New §§ 860 to 896, inclusive, filed 12-24-47 as an emergency designated to 
be effective 1-1-48 (Register 10, No. 8). 



2. Revision (§§ 860-875.0) filed 9-13-48 (Register 14, No. 1). 

3. Repealer of Group 4 (Sections 860.0-875.0) filed 8-1-75; effective thirtieth day 
thereafter (Register 75, No. 3 1 ). For prior history, see Register 10, No. 8; 1 4, No. 

1; 23, No. 7; 24, No. 5; 25, No. 2; 71, No. 10; 72, No. 16; 72, No. 32. 



Group 5. Public Medical Institutions 

NOTE: Authority cited for Sections 880 and 881: Section 212, Health and Safety 
Code. 

History 

1 . New Group 5 (§§ 880 and 881 ) filed 5-28-53, as an emergency effective upon 
filing (Register 53, No. 9). 

2. Repealer of Sections 880 and 881 filed 6-13-75; effective thirtieth day thereaf- 
ter (Register 75, No. 24). 



Subchapter 4. Records and Statistics 

(Originally Printed 8-15^5) 



Article 1. Access to the Records in the 

Office of the State Registrar and in the 

Offices of Local Registrars 

§ 901 . Access to the Records in the Office of the State 
Registrar and in the Offices of Local 
Registrars. 

Records of birth, death, and marriage in the Office of the State Regis- 
trar and in offices of local registrars for which access is not specifically 
prohibited by statute shall be open for examination by the public during 
regularly scheduled office hours subject to the restrictions listed in 
Health and Safety Code Sections 10125.5 and 10129. 

The principal researcher who needs access to confidential information 
shall submit a signed agreement to the State Registrar with a copy to the 
local registrar when appropriate, assuring that any report shall not identi- 
fy an individual and that working papers which may permit such identifi- 
cation shall be destroyed as set forth in the agreement. Any breach of the 
signed agreement shall result in denial of further access to the data. 

No person, except as authorized by law, shall copy or retain copies of 
confidential data unless procedures in this section are followed. 
NOTE: Authority cited: Secfion 6253, Government Code; and Secfions 10001 and 
10001.1(b), Health and Safety Code. Reference: Sections 10066 and 10125.5, 
Health and Safety Code. 

History 

1 . Amendment filed 1-9-78; effecfive thirtieth day thereafter (Register 78, No. 2). 
For prior history, see Register 76, No. 12. 

2. Amendment filed 2-8-78 as an emergency; effective upon filing (Register 78, 
No. 6). 

3. Certificate of Compliance filed 5-1-78 (Register 78, No. 1 8). 

4. Amendment filed 2-13-85; effecfive thirtieth day thereafter (Register 85, No. 

V). 

§ 902. Conditions of Examination. 

(a) Authorization to examine the index or records in the Office of the 
State Registrar and in offices of the local registrars must be obtained from 
the registrar or deputy in charge. 

Written application shall be made by the applicant stating sufficient in- 
formation to identify the record or records to be examined. 

The following information for the type of record specified below 
should, whenever possible, be provided by the applicant: 

(1) Birth 

(A) Name of child; 

(B) Maiden name of mother; 

(C) Date or year of birth. 

(2) Death 

(A) Name of decedent; 

(B) Date or year of death, or date last known alive; 

(C) Date or year of birth. 



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(3) Marriage 

(A) Name of Groom or Maiden name of Bride; 

(B) Date or year of marriage. 

Where the above information is not available, tlie applieant shall pro- 
vide whatever information is available, and the State Registrar or local 
registrar shall make all reasonable effort to locate the requested records. 

(b) The State Registrar or local registrar shall supervise the examina- 
tion of the records. 

NOTH: Authority cited: Section 6253, Government Code; and Sections 10001 and 
10001.1, Health and Safety Code. Reference: Section 10066, Health and Safety 
Code. 

History 

1. Amendment filed 12-24-7.5 as an emergency; effective upon filing (Regi.ster 
75, No. 52). For prior history, see Register 64, No. 4. 

2. Amendment filed 2-27-76 as an emergency; effective upon filine (Register 76, 
No. 9). 

.3. Certificate of Compliance as to the 1 2-24-75 and 2-27-76 filings filed 3-1 8-76 
(Register 76, No. 12). 

4. Amendment filed 2-13-85; effective thirtieth day thereafter (Register 85, No. 
7). 

§ 903, Fee for Examination or Search. 

NOTK: Authority cited: Secfions 10001 and 10001.1(b), Health and Safety Code. 
Reference: Section 10066, Health and Safety Code. 

History 

1 . Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 
18). 

2. Amendment filed 2-1 1-64; effective thirtieth day thereafter (Register 64, No. 

4). 

3. Repealer filed 2-13-85; effective thirtieth day thereafter (Register 85, No. 7). 



Article 2. 



Late Registration of Births and 
Deaths 



§ 908. Late Registration of Births and Deaths. 

The local registrar and the State Registrar of Vital Statistics shall ac- 
cept for registration only those records of birth and death which are re- 
ceived by the local registrar within one year of the date of occurrence of 
the event, except as provided under Division 9, Chapters 9 and 10 of the 
Health and Safety Code. 

NOTH: Authority cited: Section 10001, Health and Safety Code. Reference: Sec- 
tion 10577, Health and Safety Code. 

History 

1 . New section filed 2^-47 (Register 7). 

2. Amendment filed 3-8-55; effective thirtieth day thereafter (Register 55, No. 4). 

3. Amendment tiled 10-22-57; effective thirtieth day thereafter (Register 57, No. 
18). 

4. Editorial correction of NOTE filed 3-22-84 (Register 84, No. 12). 



Article 3. 



Birth Certificates of Deceased 
Persons 



§ 910. Responsibilities of Local Registrar or County 
Recorder. 

(a) Upon notification by the State Registrar that a person whose birth 
is registered in the local office is deceased, the local registrar or county 
recorder of such office shall make at least one of the following: 

( 1 ) A notation of the death in the birth index. 

(2) A notation of the date of death and the death certificate number 
upon the record of birth. 

(b) The local registrar or county recorder shall notify the State Regis- 
trar of any application for a certified copy of a deceased person's birth 
certificate in which it is indicated that the requested birth record is the 
applicant's own birth record. 

(c) A birth card form shall not be issued where the birth record indi- 
cates the registrant is deceased. 



NOTK: Authority cited: Sections 1 0001 and 1 0575.5, Health and Safety Code. Ref- 
erence: Sections 10038, and 10575.5, Health and Safety Code. 

History 

1. Renumbering of Article 3 to Article 4 and new Article 3 (Sections 910-912) 
filed 5-1-78; effective thirtieth day thereafter (Register 78, No. 18). 

2. Editorial correction of NOTE filed .3-22-84 (Regi.ster 84, No. 12). 

§ 911 . Identification of Deceased Registrants by Local 
Registrars and County Recorders. 

Local registrars and county recorders may match deaths occurring in 
their jurisdictions to births registered in their office and, for any regis- 
trants thereby identified as deceased, make any of the notations specified 
in Secuon 910(a)(1) and (2). 

Note: Authority cited: Sections 10001 and 10575.5. Health and SafetvCode. Ref- 
erence: Sections 10038 and 10575.5, Health and Safety Code. 

History 
1 . New NOTE filed 3-22-84 (Register 84, No. 12). 

§ 91 2. Certified Copies of Birth Certificates of Deceased 
Persons. 

(a) All certified copies of birth records for which the registrant is iden- 
tified as deceased shall display the legend "DECEASED," which shall 
be in boldface style not less than one-half inch in height, near the space 
reserved for the registrant's name. 

( 1 ) Unless produced by a photographic process or through the medium 
of an overlay employed in the copying process, the legend "DE- 
CEASED" shall be printed or stamped in indelible ink. 

(2) The local registrar or county recorder shall obtain prior approval 
by the State Registrar of the method to be employed in producing the leg- 
end "DECEASED." 

NOTE: Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Ref- 
erence: Sections 10038 and 10575.5, Health and Safety Code. 

History 
1. New NOTE filed 3-22-84 (Register 84, No. 12). 



Article 4. 



Definitions of Live Birth and Fetal 
Death 



§915. Live Birth. 

"Live birth" means the complete expulsion or extraction from its 
mother of a product of conception (irrespective of the duration of preg- 
nancy) which, after such separation, breathes or shows any other evi- 
dence of life such as beating of the heart, pulsation of the umbilical cord, 
or definite movement of voluntary muscles, whether or not the umbilical 
cord has been cut or the placenta is attached. 

NOTE: Authority cited: Section 10001, Health and Safety Code. Reference: Sec- 
tions 10100 and 10102, Health and Safety Code. 

History 

1 . New Article 3 (§§ 915 and 916) filed 6-14-.56; effective thirtieth day thereafter 
(Register 56, No. 12). For history of former Article 3, see Register 55, No. 4. 

2. Renumbering of Article 3 to Article 4 (Sections 915 and 916) filed 5-1-78; ef- 
fective thirtieth day thereafter (Register 78, No. 1 8). 

3. Editorial correction of NOTE filed .3-22-84 (Register 84, No. 12). 

§916. Fetal Death. 

"Fetal death" means a death prior to the complete expulsion or extrac- 
tion from its mother of a product of concepfion (irrespective of the dura- 
tion of pregnancy); the death is indicated by the fact that after such sepa- 
rafion, the fetus does not breathe or show any other evidence of life such 
as beating of the heart, pulsation of the umbilical cord or definite mo\e- 
ment of voluntary muscles. Registration of fetal deaths is subject to the 
provisions of Division 9, Chapter 4 of the Health and Safety Code. 
Note: Authority cited: Section 10001, Health and Safety Code. Reference: Sec- 
tion 10175, Health and Safety Code. 

History 

1 . Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57. No. 
18). 

2. New NOTE filed 3-22-84 (Register 84, No. 12). 



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Title 17 



Subchapter 5. Home Health Agency 
Licensing Requirements 

NciTH; Authority cited: Section 208(a), Health and Safety Code. Reference: Sec- 
tions 1725. 1726, 1727, 1728, 1728.1, 1729. 1731, 1734. 1735. 1736, 1737, 
1737.5, 3123 and 3124, Health and Safety Code. 

History 

1. New Subchapter 5 (§§ 917 through 947) filed 7-1-66 as an emergency; effec- 
tive upon filing (Register 66, No. 20). 

2. Certificate of Compliance— Section 1 1422. 1. Gov. Code, filed 10-25-66, as to 
emergency filing on 7-1-66 (Register 66, No. 37). 

3. Amendment filed 10-25-66; effective thirtieth day thereafter (Register 66. No. 

4. Amendment filed 12-1 3-66; effective thirtieth day thereafter (Register 66. No. 

44). 

5. Repealer of Subchapter 5 (Articles 1-9, Sections 917-948) filed 6-21-79; ef 
fective thirtieth day thereafter (Register 79, No. 25). For prior history, see Reg- 
isters 67, No. 2; 69. No. 13; 72, No. 36; 72, No. 53; 75, No. 24; 76, No. 41; 77, 
No. 5; 78, No. 45; and 79, No. 18. 



Chapter 2. Laboratories 

(Originally Printed 8-15-45) 



Subchapter 1. Service Laboratories 



Group 1. 



Production and Distribution of 
Biologies 



Article 1 . Licenses 

§ 950. General Provisions. 

(a) As used in this chapter "person" includes firm, association and cor- 
poration. 

(b) As used in this chapter "department" means State Depaitment of 

Health. 

NOTE: Authority cited for Group 1 (§§ 950 to 1021, inclusive): Secfions 208, 
1600, 1603, 1604, 1605, and 1606, Health and Safety Code. Issuing agency: State 
Department of Public Health. 

History 

1. Amendment of subsection (b) filed 3-5-76; effective thirtieth day thereafter 
(Register 76, No. 10). For prior history, see Register 20, No. 6. 

§ 951 . Issuance of License. 

(a) All persons desiring to produce process or distribute biologies shall 
make application to the department on a form provided by the depart- 
ment, and shall supply such other information as may be required by the 
department for the intelligent appraisal of the status of the laboratory, the 
product to be licensed, and the personnel with respect to the intent and 
purpose of the law. 

(b) Licenses shall not be issued to any person not at the time fully pre- 
pared, equipped and actually processing (though not distributing), but 
the department will provide anyone contemplating the establishment of 
a processing laboratory with full information concerning the require- 
ments and conditions for the preparation of the products that it is pro- 
posed to manufacture or distribute. 

(c) A license shall not be issued unless and until the estabhshment is 
prepared to operate under the direct supervision of a competent person 
trained in bacteriological technic and in the preparation of biologies as 
defined in Section 1601, Health and Safety Code, whose qualifications 
have been approved by the department. 

(d) A license shall not be issued unless the condition of the establish- 
ment and methods of preparation are such as to reasonably insure that the 
biologies produced will not be contaminated, dangerous, or harmful. 



(e) A license shall not be issued for the preparation of any biologic as 
defined in Section 1601, Health and Safety Code, if advertised so as to 
mislead or deceive the purchaser, or if the package or container in which 
the same is intended to be sold, bartered, exchanged, or shipped, bears 
or contains any statement, design, or device which is false or misleading 
in any particular. 

(f) A license shall not be issued for a biologic product that has been 
specifically forbidden or disapproved by the United States Department 
of Health, Education and Welfare excepting products that may be specifi- 
cally approved by the department, for experimental purposes but not for 
general sale and distribution. 

(g) A license shall not be issued for the processing or distributing of 
any product without satisfactory scientific evidence of therapeutic or 
prophylactic value. 

History 
1. Amendment of subsection (f) filed 3-5-76; effective thirtieth day thereafter 
(Register 76, No. 10). 

§ 952. Application for Renewal of License. 

Each licensee applying for renewal of license shall be subject to such 
review of his activities during the previous licensing period, and to such 
inspections of his premises, equipment and biologies produced by him 
as may be determined by the department for consideration in passing 
upon the application for renewal. Similarly, such licensee shall submit 
such data, records, and samples of products as may be designated by the 
department. 

History 
1 . Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 

10). 

§ 953. License Fees. 

The fees for license application and for annual license renewal are six 
hundred dollars ($600). 

NOTE; Authority cited: Secfions 102, 208, Health and Safety Code. Reference: 
Sections 1600-1616, Health and Safety Code. 

History 
1. New section filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 

10). 



Article 2. Exemptions 

§ 956. Autogenous Vaccines. 

Laboratories whose principal activity is general clinical work and 
whose only biologic product is autogenous bacterial vaccines do not re- 
quire a license for the preparation of autogenous vaccines unless the 
making of autogenous vaccines constitutes 10 percent or more of the ac- 
tivity or source of income of the laboratory. 

Article 3. Inspection and Records 

§ 962. inspection by Department. 

(a) Each licensee or applicant shall permit any duly authorized em- 
ployee of the department to enter his establishment at any reasonable 
hour, and shall permit said representative of the department to inspect 
without previous notification the entire premises of such establishment, 
including all buildings, compartments, and other places, and all equip- 
ment, such as chemicals, instruments, apparatus, and the like, as well as 
the methods used in the manufacture of, and all records maintained rela- 
tive to biologies as defined in Section 1601, Health and Safety Code. 

(b) Each licensee or applicant shall provide to the department such 
stock cultures or other materials from which biologies are produced and 
such completed products as may be required by the department for test- 
ing of identity, purity, potency or other analysis. 

§ 963. Records. 

The licensee shall keep records of the source of the preparation, of tests 
for purity and potency, and of the methods of preparation of each batch 
of biologies as defined in Section 1601 , Health and Safety Code, and the 



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sale, shipment or other disposition of the same. The licensee shall supply 
to the department monthly, on forms provided by the department, such 
information from said records as the department may require, the licens- 
ee retaining a full and complete copy thereof in his files. 

Article 4. Storage 

§ 967. Storage. 

Each licensee shall maintain a refrigerator of sufficient capacity to 
store all of those products in his possession which require refrigeration 
and the entire stock of such products shall be kept within the refrigerator 
at all times. The temperature of the refrigerator shall not be permitted to 
rise above 10 degrees C. or fall below 1 degree C, as indicated by a re- 
quired standard mercury thermometer, except that storage below 1 de- 
gree C. is allowed if not specifically damaging to the product. Licensee 
shall not sell or distribute for resale or redistribution biologies which re- 
quire refrigeration unless the purchaser or distributor for resale or redis- 
tribution is equipped to store said biologies in the manner above pro- 
vided. 



Article 5. Containers and Labeling 

§ 972. Containers and Labeling. 

(a) No biological product either for human or animal use shall be dis- 
tributed except in the original final container bearing the original label 
of the manufacturer; provided, however, that a licensed laboratory may 
purchase products from other producers likewise licensed by the State, 
and repack and relabel such products in smaller containers; provided, 
there are no changes, substitutions or additions in the product or the label, 
and further provided, that all such repacked biological products shall bear 
on the label the name of the manufacturer as well as the name of the dis- 
tributor together with a statement that the product has been repacked. All 
such repacked products are subject to the requirements of Sections 1 600 
to 1621, inclusive. Health and Safety Code, and are not exempted from 
inspection and license by the department. 

(b) The labels of all biologic products on the containers for general dis- 
tribution shall show the name of the product, the lot number that will 
identify the lot or batch in the record of the manufacturer, the expiration 
date, and the name of the manufacturer. The expiration date shall be 
based on a period of duration approved by the department. 

(c) The labels on all bottles and individual packages of bacterial vac- 
cines (bacterins) shall give the correct name of the organism concerned 
and mixed bacterins shall give the names of each organism according to 
the classification of Bergey in the mixture and the proportion that each 
organism represents in the mixture. The concentration may be expressed 
in number per mil or in terms of a turbidity standard acceptable to the de- 
partment. 

(d) The labels on products requiring refrigeration or maintenance of 
uniform temperatures to avoid deterioration, shall specify the tempera- 
ture range within which the product shall be maintained. 

(e) To prevent accidental use, all stocks of labels and advertising not 
accepted by the department shall be destroyed. 

History 
1 . Repealer of subsection (e) and relettering of subsection (f) to (e) filed 8-16-7 1 ; 
effective thirtieth day thereafter (Register 71, No. 34). 



Article 6. Advertising 

§ 977. Advertising. 

(a) No statements regarding preventive or therapeutic value shall be 
made either on labels or circulars or in any form of advertising that are 
not in accord with the opinion held by the recognized authorities of the 
medical profession and no descriptive matter or discussion of mode of 



action of the product or theory of its applicability may be used that is not 
acceptable to the same authorities. 

(b) No mention of the department shall be made in advertising either 
directly or indirectly. 

(c) All advertising matter, statements, and representations pertaining 
to biologies licensed under Sections 1600 to 1620, Health and Safety 
Code, shall be submitted to the department at least 30 days prior to their 
use by the licensee. 

History 
1. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76. No. 
10). 



Article 7. Samples 

§ 982. Potency. 

Licensees producing, processing or distributing biologies for which a 
potency test is recognized or prescribed by the United States Department 
of Health, Education, and Welfare, shall upon the request of the depart- 
ment, provide a representative sample of each lot of such product for pur- 
poses of checking. The particular lot so sampled shall not be distributed 
until approval is given by the department. 

History 
1. Amendment filed 3-5-76; effective thirtieth dav thereafter (Register 76, No. 

10). 



Article 8. Vaccine Culture 

§ 987. Vaccine Culture. 

No culture shall be used in the preparation of live culture vaccine un- 
less it is nonvirulent or has sufficiently low virulence as not to be reason- 
ably likely to produce the disease in the inoculated person, or be danger- 
ous from the standpoint of contagion. Such cultures must be tested and 
approved by the department before use. 

History 
1. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 
10). 



Article 9. Preparation and Distribution of 
Whole Blood (Human) 

The following condifions must be met and observed in the procure- 
ment, processing, storage, and distribution of whole blood (human) or 
blood derivadves for transfusion purposes: 

§ 997. Definitions. 

As used in this article: 

(a) Blood Bank is a medical facility designed, equipped, and staffed 
to procure, to process, to store, or to distribute human whole blood or 
blood derivadves for transfusion purposes. 

(b) For implementadon of these reguladons, a blood bank depository 
also is designated as a transfusion service. 

A transfusion service shall be a component of a clinical laboratory 
holding a license in accordance with the provisions of Chapter 3 (com- 
mencing with Secdon 1200) Division 2 of the Business and Professions 
Code, or such other place where services essendally equivalent are main- 
tained as determined by the department. 

A transfusion service shall be responsible for all functions related to 
storage and preparation of blood for transfusion, except those activities 
requiring a biologies license, in accordance with the Health and Safety 
Code, Division 2, Chapter 4 (commencing with Section 1 600). 

Institutions which fulfill criteria for both a clinical laboratory license 
and a biologies license may maintain the combined services of a blood 
bank and a transfusion service. 

(c) Blood collection center is a stationary auxiliary to a blood bank 
which is designed, equipped and staffed to procure human whole blood 
and to transport this blood to the blood bank for processing, storing and 
distribution. 



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(d) Mobile unit is a transportable auxiliary to a blood bank designed, 
equipped, and staffed to procure human whole blood and to transport this 
blood to the blood bank for processing, storing and distribution. 

(e) Whole blood is the fluid component of the human cardiovascular 
system composed of liquid and cellular elements. 

(f) Plasma is the extracellular portion of anticoagulated whole blood. 

(g) Blood derivatives or fractionation products are the individual ele- 
ments of whole blood which have been processed or manufactured into 
their individual component parts, in accordance with procedures con- 
tained in Articles 10 and 11. 

(h) Donor means the individual from whom blood is procured. 

(i) All references to temperature are expressed in degrees centigrade. 
NOTE: Authority cited: Sections 1602.5, 1603, 100110 and 100275, Health and 
Safety Code. Reference: Sections 1600-1620, Health and Safety Code. 

History 

1 . Repealer and new Article 10 (Sections 997 thiough 1003) filed 10-25-66; effec- 
tive thirtieth day thereafter (Register 66, No. 37). For history of former Article 
10, see Registers 56, No. 2, 59, No. 17, 60. No. 19 and 63, No. 17. 

2. Amendment of subsection (b) filed 10-25-72; effective thirtieth day thereafter 
(Register 72, No. 44). 

3. Renumbering of Article 10 to Article 9 and amendment filed 3-5-76; effective 
thirtieth day thereafter (Register 76. No. 10). For history of former Article 9 
(Section 992) see Register 71, No. 34. 

4. Change without regulatory effect repealing subsections (i)-(k), relettering sub- 
sections, and amending Note filed 7-1 3-98 pursuant to section 100, title 1 , Cal- 
ifornia Code of Regulations (Register 98, No. 29). 

§ 998. Personnel of Blood Banks and Their Auxiliaries. 

(a) Physicians and surgeons, clinical laboratory bioanalysts, clinical 
laboratory technologists, clinical laboratory technologist trainees and 
nurses who comprise the staff of the blood bank shall be duly licensed by 
or registered in the State of California. The staff may include such other 
persons, when approved by the director, as may be necessary for the 
proper operation of the blood bank, including volunteer workers. 

(b) Director of Blood Bank. The blood bank and its auxiliaries shall 
be under the direction of a physician and surgeon duly licensed by the 
State of California, and who shall have a minimum of six months experi- 
ence in blood bank methods, transfusion principles, and transfusion prac- 
tices, satisfactory to the department. Attending Physician refers to the 
duly licensed physician and surgeon supervising blood collection activi- 
ties. 

(c) Laboratory Personnel. The laboratory personnel shall be licensed 
pursuant to the Clinical Laboratory Laws (California Business and Pro- 
fessions Code, Division 2, Chapter 3), except that unlicensed persons 
may be used to assist licensed personnel under their supervision, so long 
as such unlicensed persons do not perform laboratory tests or render 
judgment on such tests. 

NOTE: Authority cited: Sections 208 and 1603, Health and Safety Code. Refer- 
ence: Section 1603(c), Health and Safety Code. 

History 

1. Amendment of subsection (b) filed 7-31-68; effective thirtieth day thereafter 
(Register 68, No. 29). 

2. New NOTE filed 3-20-84 (Register 84, No. 12). 

§ 999. Blood Bank Equipment, Facilities and Manual. 

NOTE: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Ref- 
erence: Section 1602.5, Health and Safety Code. 

History 
1 . Change without regulatory effect repealing section and adopting new Note filed 
7-1 3-98 pursuant to section 100, title 1 , California Code of Regulations (Regis- 
ter 98, No. 29). 

§ 1000. Blood Bank Records; Identification of Human 
Blood with Its Donor. 

(a) A system which carries through from donor to recipient must be 
used to identify the blood. This shall be accomplished by having blood 
container and pilot tube labels identified with the donor before venesec- 
tion. The labels and personal history shall carry the same identification 
number. These labels shall accompany the donor to the collection room 
and shall be applied to the blood container and pilot tubes while it is still 
possible to check accurately the identity of the blood with the donor and 



his history. Other documents related to the blood such as invoices, if 
used, shall also contain the same identification number. 

(b) Every California licensed blood bank shall obtain reports of reac- 
tions in individuals receiving its blood, or blood derivatives, where it ap- 
pears that these materials from the blood bank may be implicated in such 
reactions. Reporting shall include also any illness whose cause may be 
related to transfusion of blood or blood derivatives provided by the blood 
bank. Forms for these purposes may be devised by the blood bank as a 
reminder to the transfusion services and as encouragement to them to 
comply with this requirement. 

(c) In addition to the applicable portions of the regulations set forth in 
Section 963 and the first two paragraphs of this section, the blood bank 
shall keep complete records of each donor, which shall include all infor- 
mation specified in Section 1002. Records are required also which con- 
tain information related to the disposition of all blood collected or distrib- 
uted. 

(d) These records shall be kept for an interval of not less than five years 
after the expiration date of the blood unit involved. All such records shall 
be correlated in such a way that checking the complete history of each 
blood unit may be quickly and conveniently performed. 

(e) Records of refrigerator temperatures shall fulfill the requirements 
contained in Section 1002(g)(2) of these regulations. 

(f) All blood bank records shall be dated. 

NOTE: Authority cited: Sections 208 and 1603, Health and Safety Code. Refer- 
ence: Section 1603, Health and Safety Code. 

History 
1 . New NOTE filed 3-20-84 (Register 84, No. 12). 

§1001. Labels. 

NOTE: Authority cited: SecUons 1 602.5 and 1 00275, Health and Safety Code. Ref 
erence: Secfion 1602.5, Health and Safety Code. 

History 

1 . Repealer of subsecrion (k) filed 4-20-77; effective thirtieth day thereafter (Reg- 
ister 77, No. 17). For prior history, see Register 76, No. 10. 

2. Change without regulatory effect repealing section and adopting new Note filed 
7-1 3-98 pursuant to section 1 00, fitle 1 , California Code of Regulations (Regis- 
ter 98, No. 29). 

§ 1002. Requirements — Donors, Medical History, Blood 
Collection, Storage and Testing. 

(a) Responsibilities. Final responsibility for the acceptance of donors 
rests with the attending physician. 

Any time blood is collected under license, adequate medical care for 
the donor shall be provided. Blood shall be drawn from the donor under 
the supervision of a physician or registered nurse trained in the proce- 
dure. Blood may be collected when a physician is not present on the 
premises under the following conditions: 

( 1 ) The medical director and his medical advisory committee, if he has 
one, must approve. 

(2) The employee placed in charge, in the absence of a qualified physi- 
cian must be a registered nurse. 

(3) The nursing staff and medical director must have a mutually clear 
understanding of the criteria for donor selection. Consultation with the 
medical director by telephone from mobile unit operations about certain 
donors may be necessary. 

(4) A qualified physician or emergency medical facility shall be avail- 
able nearby. Having a physician or emergency medical facility available 
is for the purpose of attending to donors who have a severe reaction or 
accident related to the blood donation. "Available" means no longer than 
15 minutes away. 

(5) Written emergency standing orders for donor care must be pre- 
pared by the medical director and be made available to the nursing staff. 
Appropriate training and refresher courses in emergency resuscitative 
methods must be planned. The nursing staff must be given special train- 
ing on the symptomatology and emergency treatment of such conditions 
as cardiac and vascular disease, syncope, fractures, etc. 

The attending physician shall sign all donor records, except that he 
may delegate the responsibility for signature to an employee of the blood 



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§1004 



bank whose license permits him to perform functions related to medical 
practice when under medical supervision. 

Irrespective of location, the blood bank under whose license the blood 
is to be processed shall be responsible for all personnel engaged in ex- 
amining donors and collecting blood, as well as the space and equipment 
used. 

(b) Collection of Blood. (Refer to Section 1000(a) for requirements 
relative to donor identification.) 

(1) Protection of the Donor Against Infection and Injury. 

The preparation of the skin at the sites of venipuncture and of injec- 
tions incidental to venipuncture shall be adequate to protect the donor 
against infection. 

Apparatus or instruments such as syringes, needles, and lancets or oth- 
er blood-letting devices capable of transmitting infection from one donor 
to another shall be sterile single-use instruments insofar as possible. 

All such instruments intended for reuse shall be heat sterilized prior to 
each use and protected against contamination. Heat sterilization shall be 
by autoclaving for 30 minutes at 121.5 C (15 lb. p.s.i. pressure), by dry 
heat for two hours at 1 70 C, or by boiling in water for 30 minutes. Times, 
temperatures and pressures in excess of those stated are permissible. 

Such heat sterilization shall include the use of a heat indicator satisfac- 
tory to the department, which will serve as evidence of proper steriliza- 
tion. The heat indicator used shall be retained for one year as a record re- 
lating to the sterilization in which it was used. The record of temperature 
attained shall be kept on file in the blood bank for five years. This record 
may be kept either as hand-written chart showing temperatures at differ- 
ent times, or as information from an automatic recorder. 

Instruments used in puncturing the skin, if not prepared for reuse, shall 
be disposed of in such a way that they cannot be reused. 

Thermometers shall be sufficiently cleansed before use to minimize 
the transmission of disease. 

The staff concerned with blood collection shall be instructed in the 
first aid procedures to be used in the event of a reaction, and suitable 
drugs and supplies shall be immediately available for use. Donors shall 
be kept under continuous observation throughout the entire procedure of 
blood collection and for at least 15 minutes thereafter. 

(c) Laboratory Tests. 

( 1 ) Serologic Tests for Syphilis. A serologic test for syphilis approved 
by the department shall be made on a sample of blood taken from the do- 
nor at the time of blood collection. Blood shall not be used for transfusion 
unless the result of this test is nonreactive (negative), except in emergen- 
cy situation with the consent of the blood bank director and the patient's 
attending physician. 

All California licensed blood banks must accept and test evaluation 
sera provided by the department or a proficiency testing service approved 
by the department, and report test results to the department. Any blood 
bank laboratory showing unsatisfactory performance shall make changes 
as recommended by the department. 

(d) Issue of Blood. Issuance of blood shall be in compliance with the 
provisions of the Health and Safety Code, Division 2, Chapter 4, Sections 
1600.3 and 1604. 

The laboratory tests and other procedures with respect to the prepara- 
tion of blood for transfusion after it has been delivered to a transfusion 
service by the blood bank shall be the sole responsibility of the transfu- 
sion service. (See Section 1605 of the Health and Safety Code.) 

As a condition to supplying blood, the blood bank director may inquire 
into the pretransfusion procedures used by the transfusion service and he 
may suggest as a minimum those described in the latest edition of "Stan- 
dards for Blood Banks and Transfusion Services," published by the 
American Association of Blood Banks. Blood banks shall not supply 
blood to transfusion services in which the department finds pretransfu- 
sion procedures which differ from these standards, or from such other 
standards which are essentially equivalent to these, as determined by the 
department. 

NOTE: Authority cited: Sections 1602.5 and 1603, Health and Safety Code. Refer- 
ence: Sections 1602.5 and 1603, Health and Safety Code. 



History 

1. Amendment of subsections (b) and (c) filed 5-25-77; effective thirtieth day 
thereafter (Register 77, No. 22). For prior history, see Register 76, No. 10. 

2. Amendment of subsections (a)(3), {c)(6), (g)(1) and (i) filed 1-1 8-78; effective 
thirtieth day thereafter (Register 78, No. 3). 

3. Amendment of subsection (b)(6) filed 2-6-79 as an emergency; effective upon 
filing (Register 79, No. 6). 

4. Certificate of Compliance filed 5-18-79 (Register 79, No. 20). 

5. Amendment of subsection (a)(3) filed 4-10-86; effective thirtieth day thereafter 
(Register 86, No. 15). 

6. Amendment of subsection (a)(4) filed 10-2-87: operative 10-2-87 pursuant to 
Government Code Section 1 1346.2(d) (Register 87, No. 41 ). 

7. Editorial connection of subsection (a)(2) (Register 87, No. 41). 

8. Change without regulatory effect repealing subsections (a)-(c)(6), 
(e)(2)-(g)(5), (h)(2)-(i) and (k)-(/)(4), relettering subsections, amending newly 
designated subsection (b) and amending NoTi: filed 7-13-98 pursuant to sec- 
tion 100, title 1, California Code of Regulations (Register 98, No. 29). 

§ 1 002.1 . Use of AIDS Antibody (HTLV-III) Test by Blood 
Banks. 

NOTE: Authority cited: Sections 208 and 1603, Health and Safety Code. Refer- 
ence: Section 1603, Health and Safety Code. 

History 

1. New section filed 3-8-85 as an emergency; effective upon filing (Register 85. 
No. 15). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 7-8-85. 

2. Repealer filed 5-22-85 as an emergency; effective upon filing (Register 85, No. 
22). A Certificate of Compliance must be transmitted to OAL within 120 days 
or emergency language will be repealed on 9-19-85. 

3. Emergency language filed 3-8-85 and 5-22-85 expired by operation of Gov- 
ernment Code Section 1 1346.1 (Register 87, No, 2). 

§ 1003. Exceptions for Emergency Purposes. 

In the event that an emergency occurs as defined in Chapter 7 (Califor- 
nia Emergency Services Act), Division 1 , Title 2 of the Government 
Code deviation from the provisions of Section 1001 and subsections (a) 
through (h) of Section 1002 of this Article will be permissible. The extent 
of deviation shall be determined by the blood bank director with concur- 
rence by the department and shall be commensurate with the degree of 
emergency. 

History 

1 . Amendment filed 10-25-72; effecfive thirtieth day thereafter (Register 72, No. 
44). 

§ 1004. Reporting Requirements. 

(a) Notification of Positive Laboratory Finding for Syphilis. To assist 
the local health officer in the discharge of his duties under Section 3110 
and 3 194 of the Health and Safety Code, any person who is in charge of 
a blood bank in which a laboratory examination of any specimen derived 
from a donor yields serological or other evidence of syphilis shall 
promptly notify the health officer of the local health jurisdiction of the 
address of the donor. This notification shall contain the type of specimen, 
the date it was obtained, the nature and result of the test performed, and 
the name, address, and the date of birth of the donor who provided the 
specimen. 

The notification may be made by mailing or otherwise delivering a 
legible copy of the laboratory report containing all of the required infor- 
mation or by a telephone communication which is documented in the 
blood bank's records. 

(b) The notifications required in this section are confidential and not 
open for public inspection. 

NOTE: Authority cited: Sections 1603, 1603.1(g), lOOllOand 100275, Health and 
Safety Code. Reference: Sections 1600-1616, Health and Safety Code. 

History 

1. New section filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 
10.) 

2. Amendment of subsection (a) filed 3-8-85 as an emergency; effective upon fil- 
ing (Register 85, No. 15). A Certificate of Compliance must be transmitted to 
OAL within 120 days or emergency language will be repealed on 7-8-85. 

3. Repealer and new subsection (a) filed 4-2-85 as an emergency; effective upon 
filing (Register 85, No. 15). A Certificate of Compliance must be transmitted 
to OAL within 120 days or emergency language will be repealed on 7-31-85. 

4. Subsecfion (a) repealed by operation of Government Code Section 11346.1(g) 
(Register 85, No. 37). 



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§1010 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



5. Repealer and new subsection (a) filed 9-1 1-K3 as an emergency; effective upon 
filing. Certificate of Compliance included (Register 83, No. 37). 

6. Change without regulatory effect repealing subsections (a)-(c), relettering sub- 
sections, and amending Noxti filed 7-1 3-98 ))ursuant to section 1 00, title 1 , Cal- 
ifornia Code of Regulations (Register 98, No. 29). 



Article 10. Preparation and Distribution of 
Normal Human Plasma 

The following must be met and observed for the procurement, process- 
ing, storage and transportation of human blood for plasma: 

§ 1010. Procurement of Blood for Plasma Processing. 

NOTE: Authority cited: Sections 1603, 100110 and 100275, Health and Safety 
Code. Reference: Sections 1600-1620, Health and Safety Code. 

History 

1 . Repealer and new Article 1 1 (Sections 1010 through 1022) filed 10-25-66; ef- 
fective thirtieth day thereafter (Register 66, No. 37). For history of previous Ar- 
ticle 1 1, see Registers 56, No. 2 and 59, No. 17. 

2. Amendment of subsection (b) filed 1 1-24-69; effective thirtieth day thereafter 
(Register 69, No. 48). 

3. Renumbering of Article 11 to Article 10 and amendment filed 3-5-76; effective 
thirtieth day thereafter (Register 76, No. 10). 

4. Change without regulatory effect repealing section and amending NoTt- filed 
7-13-98 pursuant to section 100, tide 1, California Code of Regulations (Regis- 
ter 98, No. 29). 

§ 1011. Personnel and Equipment. 

Blood shall be processed into plasma only in blood banks adequately 
staffed and equipped for that purpose. The individual directly in charge 
of plasma processing shall be a physician and surgeon duly licensed by 
the State of California or an individual sufficiently trained in laboratory 
procedures relating to blood banking and plasma processing and whose 
qualifications have been approved by the department. The staff may in- 
clude other trained persons necessary for the proper operation of plasma 
processing. 

§ 1012. Single Donor Plasma and Single Donor Fresh 
Frozen Plasma (Antihemophilic). 

NOTE: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Ref- 
erence: Section 1602.5, Health and Safety Code. 

History 

1. Amendment filed 4-1-71; effective thirtieth day thereafter (Register 71, No. 
14). 

2. Renumbering from Section 1022 and amendment filed 10-25-72; effective thir- 
tieth day thereafter (Register 72, No. 44). For history of former Secfion 1012, 
see Register 71, No. 14. 

3. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 1 0. 

4. Change without regulatory effect repealing section and adopting new Note filed 
7-1 3-98 pursuant to secfion 1 00. title 1 , California Code of Regulations (Regis- 
ter 98, No. 29). 

§1013. Storage. 

NOTE; Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Ref- 
erence: Section 1602.5, Health and Safety Code. 

History 

1 . Renumbering from Section 1019 and amendment filed 1 0-25-72; effective thir- 
tieth day thereafter (Register 72, No. 44). For history of former Section 1013, 
see Register 71, No. 14. 

2. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 
10.) 

3 . Change without regulatory effect repealing section and adopting new Note filed 
7-1 3-98 pursuant to section 100, title 1, California Code of Regulations (Regis- 
ter 98, No. 29). 

§ 1014. Expiration Date. 

NOTE: Authority cited: Sections 1602.5 and 1 00275, Health and Safety Code. Ref- 
erence: Section 1602.5, Health and Safety Code. 

History 

1 . Renumbering from Section 1 020 and amendment filed 1 0-25-72; effective thir- 
tieth day thereafter (Register 72, No. 44). For history of former Section 1020, 
see Register 71, No. 14. 

2. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 
10.) 



3. Change without regulatory effect repealing section and adopting new Note filed 
7- 1 3-98 pursuant to section 1 00, title 1 , California Code of Regulations (Regis- 
ter 98, No. 29). 



§1015. Other Tests. 

History 
1 . Repealer filed 1 0-25-72; effective thirtieth day thereafter (Register 72. No. 44). 

§ 1 01 6. Filling the Final Container. 

History 
1 . Repealer filed 1 0-25-72; effective thirtieth day thereafter (Register 72, No. 44). 

§1017. Labeling. 

History 
1 . Repealer filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44). 

§ 1 01 8. Diluent for Dried Plasma. 

History 
1 . Repealer filed 1 0-25-72; effective thirtieth day thereafter (Register 72, No. 44). 

§ 1 021 . Requirements for Release. 

History 
1 . Repealer filed 1 0-25-72; effective thirtieth day thereafter (Register 72, No. 44). 



Article 1 1 . Preparation of Other Blood 
Derivatives 

§ 1 024. Red Blood Cells (Human). 

NOTE: Authority cited: Sections 1603, 100110 and 100275, Health and Safety 
Code. Reference: Sections 1600-1620, Health and Safety Code. 

History 

1. Repealer of Article 12 (§§ 1025-1026) filed 10-25-66; effective thirtieth day 
thereafter (Register 66, No. 37). for former history of Article see Registers 56, 
No. 2 and 61, No. 3. 

2. Amendment filed 4-1-71; effective thirtieth day thereafte:: (Register 71, No. 
14). 

3. Renumbering of Article 12 to Article 11 and amendment filed 3-5-76; effective 
thirtieth day thereafter (Register 76, No. 10). 

4. Change without regulator}' effect repealing section and amending Note filed 
7-1 3-98 pursuant to section 100, title 1 , California Code of Regulations (Regis- 
ter 98, No. 29). 

§ 1 024.1 . Frozen Red Blood Cells. 

NOTE; Authority cited: Sections 1602.5, 1001 10 and 100275, Health and Safety 
Code. Reference: Sections 1600-1616, Health and Safety Code. 

History 

1. New section filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 
10). 

2. Change without regulatory effect repealing section and amending Note filed 
7-13-98 pursuant to section 1 00, tide 1 , Cahfomia Code of Regulations (Regis- 
ter 98, No. 29). 

§1025. Plasmapheresis. 

(a) Requirements: 

( 1 ) No more than 500 milliliters of whole blood shall be removed from 
a donor at one time, unless the donor's weight is 175 pounds or greater 
in which case no more than 600 milliliters of whole blood shall be re- 
moved from the donor at one time. 

(2) A duly licensed physician and surgeon shall be available as de- 
scribed in Section 1002(a) when plasmapheresis is performed. 

(3) A system shall be employed which gives maximum assurance 
against any possibility of return of the separated red cells to an individual 
other than their donor. 

(b) Examination and Laboratory Tests. Examinations and laboratory 
tests to assist in determining the donor's health shall include the follow- 
ing: 

(1) Within no more than one week prior to the initial plasmapheresis, 
the donor shall be examined and certified to be in good health by a duly 



Pages 



Register 98, No. 29; 7-17-98 



Title 17 



State Department of Health Services 



§1029 



licensed physician and surgeon, as indicated in the applicable sections of 
the regulations. All donors shall have a physical examination by a duly 
licensed physician and surgeon at least once a year. 

(2) A whole blood hemoglobin or hemoglobin or hematocrit concen- 
tration shall be performed prior to each plasmapheresis procedure. 

(3) Determination of total protein shall be done at the time of each plas- 
mapheresis procedure, the total protein shall not be less than 6.0 grams 
per 1 00 ml of plasma. 

(4) The ratios of the various protein components of the donor's serum 
shall be determined from a sample taken at the time of his initial plasmap- 
heresis and at intervals of not more than four months thereafter so long 
as he remains on a plasmapheresis program. 

(5) To qualify for further plasmapheresis, all of the values determined 
under this section must be within the acceptable normal range. 

(c) Samples for Laboratory Tests. Samples for laboratory tests shall 
not exceed 30 ml of whole blood in a seven-day period. 
NOTE: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Ref- 
erence: Section 1602.5, Health and Safety Code. 

History 

1 . Amendment filed 1 1-24-69; effective thirtieth day thereafter (Register 69, No. 

48). 

2. Amendment filed 3-5-76; effective thirtieth day thereafter (register 76, No. 10). 

3. Change without regulatory effect repealing subsections (a)-(b)(2)(B), 
(c)(l)-(c)(3) and (e)-(e)(l), relettering subsections, amending newly desig- 
nated subsections (a)(2) and (b)(2) and adopting new Note filed 7-13-98 pur- 
suant to section 100, title 1, California Code of Regulations (Register 98, No. 
29). 



§ 1026. Other Blood Fractions; Procedures; Standards; 
Consultative Service. 

Since procedures and standards for the preparation of other blood frac- 
tions, such as immune serum globulin, albumin, etc., for transfusion pur- 
poses are not as yet well suited for blood bank production, any biologies 
producer operating under the license of the department shall submit a 
complete protocol of procedures to be followed and shall be subject to 
the current specifications of the department regarding such products. 
This shall include specific licensure for the production of such materials, 
inspection, and the maintenance of appropriate standards. Such stan- 
dards as are necessary will, in general, follow the usual blood banking 
procures with deviations general, follow the usual blood banking proce- 
dures with deviations only for specific reason. Such deviations and spe- 
cific procedures shall be outlined in writing to the department by the bio- 
logics producer. Potential producers of such biologies should avail 
themselves of the consultative services of this department in order to pro- 
vide for a proper production procedure consistent with regulations of the 
department, thus avoiding the installation of methods which must later 
be amended or changed. 

History 

1 . Amendment filed 3-5-76; effective thirtieth day thereafter (register 76, No. 10). 



Article 12. 



Transportation of Etiologic 
Agents 



§ 1027. Definitions and Procedures to Be Followed. 

(a) For the purpose of this article "person" includes laboratory, firm, 
association, corporation, co-partnership, and educational institutions, 
and "department" means State Department of Health. 

(b) Etiologic Agents. 

( 1 ) For the purpose of this article microorganisms which may produce 
disease in man shall be referred to as etiologic agents. 

(2) The provisions of this article do not apply to specimens transmitted 
to a laboratory operated by the State Department of Health or equivalent 
containers are used, or those of other public health department laborato- 
ries operating under certificates issued by the department. 



(3) The provisions of this article do not apply to biological products 
licensed by the department or by the United States Department of Health, 
Education and Welfare. 

(c) The following safety measures shall be used by persons initiating 
the transportation of etiologic agents. 

( 1 ) Containers shall be used which are constructed in a manner equiva- 
lent to those referred to in (b)(2) of this section. 

(2) In the case of frozen materials the etiologic agent shall be packed 
in sufficient dry ice and insulation material to insure that the material will 
remain frozen for at least 24 hours longer than the expected time in trans- 
portation. 

(3) The proposed recipient shall be notified when transportation of the 
etiologic agent begins. This shall include type of transportation and prob- 
able time of arrival at a designated place. 

(4) The approved type of container, referred to in (b)(2) above, shall 
be labeled in such a way that the etiologic agent which it contains is clear- 
ly indicated in bold type. Tlie label shall state cleariy that material of an 
infectious nature is present within the container. 

(5) The label shall state that if breakage or leakage occurs whoever first 
has knowledge of the accident will immediately notify the department 
and the local health officer having jurisdiction at the site of the accident. 
This report should also contain the names and addresses of those who 
may have been exposed to the etiologic agent as a result of the accident. 
If loss occurs the person first aware of this occurrence shall notify the de- 
partment promptly and shall supply such additional details as may be 
available. 

NOTE: Authority cited: Secfions 102 and 208, Health and Safety Code. Reference: 
Secfion 1603.5, Health and Safety Code. 

History 

1. New secfion filed 2-1 -6 l;effecdve thirtieth day thereafter (Register 61, No. 3). 

2. Amendment filed 3-5-76; effecfive thirtieth day thereafter (Register 76, No. 
10). 



Article 13. Research Projects 

§ 1 028. Waiver of Regulations. 

Notwithstanding the other provisions of Group 1 , Subchapter 1 , Chap- 
ter 2 of Part I (commencing with Section 950) of Title 17 relating to the 
production and distribution of biologies, the Director may at his discre- 
tion waive such regulations for research projects approved by the Direc- 
tor. The waiver shall be for a specific period of time and subject to all con- 
ditions which the Director finds necessary to protect the public health. 
NOTE; Authority cited: Section 102 and 208, Health and Safety Code. Reference: 
Secfions 1600-1616, Health and Safety code. 

History 
1. New Article 13 (Section 1028) filed 3-5-76; effecfive thirtieth day thereafter 

(Register 76, No. 10). 



Group 2. Clinical Laboratory Regulations 



Article 1. Definitions 

§ 1029. General Definitions. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209. 1220, 
1241, 1244, 1265, 1281, 1282, 1285, 1288.5 and 1300, Business and Professions 
Code. 

History 

1. Amendment of group, article and section headings, and renumbering and 
amendment of former secfion 1053 to section 1029 filed 1-22-96 as an emer- 
gency; operative 1-22-96 (Register 96, No. 4). A Certificate of Compliance 
must be transmitted to OAL by 5-21-96 or emergency language will be re- 
pealed by operation of law on the following day. 

2. Amendment of section and Note filed 5-28-96 as an emergency; operative 
5-28-96 (Register 96, No. 22). A Certificate of Compliance must be transmitted 
to OAL by 9-25-96 or emergency language will be repealed by operation of law 
on the following day. 

3. Editorial correction of subsection (gg) (Register 96, No. 25). 



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§ 1029.5 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



4. Certificate of Compliance as to 1-22-96 order including amendment of Note 
transmitted to OAL 5-21-96 and filed 6-18-96 (Register 96, No. 25). 

5. Editorial correction of subsection (k)(l) (Register 96, No. 41). 

6. Amendment of section and Noth refiled 10-7-96 as an emergency; operative 
10-7-96 (Register 96, No. 4 1 ). A Certificate of Compliance must be transmitted 
to OAL by 2-4-97 or emergency language w ill be repealed by operation of law 
on the following day. 

7. Amendment of article heading filed 11-6-96 as an emergency; operative 
1 1-6-96 (Register 96, No. 45). A Certificate ofCompliance must be transmitted 
to OAL by 3-5-97 or emergency language u ill be repealed by operation of law 
on the following day. 

8. Certificate ofCompliance as to 10-7-96 order, including repealer of section, 
transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12). 

9. Certificate ofCompliance as to 1 1-6-96 order transmitted to OAL 3^1-97 and 
filed 4-15-97 (Register 97, No. 16). 



§1029.5. Accreditation Body. 

"Accreditation body" means an approved accreditation organization 
for laboratories, as defined in 42 Code of Federal Regulations, Section 
493.2. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1223, 1265, 1281 and 
1288.5, Business and Professions Code. 

History 

1 . New secfion filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

§1029.6. Accredited Institution. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1223, 1265, 1281 and 
1288.5, Business and Professions Code. 

History 

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Change without regulatory effect renumbering former section 1029.6 to section 
1029.9 filed 5-14-2001 pursuant to section l(To,fitle 1, California Code of Reg- 
ulations (Register 2001, No. 20). 



§ 1029.7. Accredited College or University. 

"Accredited college or university" means an educational facility 
which has met the standards of the United States of America Accrediting 
ComiTiission for Senior Colleges and Universities or the Accrediting 
Commission for Community and Junior (Colleges; or, if a non-United 
States college or university, one that is evaluated and found equivalent 
by the American Association of Collegiate Registrars and Admissions 
Officers. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference; Sections 1260, 1261, 1261.5, 1263 
and 1264, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate ofCompliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 1 0-1 9-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 



§1029.9. Accredited Institution. 

"Accredited institution" has the same meaning as given in Title 42 of 
the Code of Federal Regulations, Section 493.2. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfion 120775, Health and Safety 
Code. 

History 

1 . Change without regulatory effect renumbering former section 1029.6 to section 
1029.9 filed 5-14-2001 pursuant to section 100, title 1, California Code of Reg- 
ulafions (Register 2001, No. 20). For prior history, see Register 98, No. 7. 



§1029.10. Accusation. 

"Accusation" means a written statement filed in order to initiate a 
hearing to determine whether a right, authority, license, or privilege 
should be revoked, suspended, limited or conditioned, and which: 

(a) Sets forth in ordinary and concise language the acts or omissions 
with which a person, entity, or laboratory and its owners or directors are 
charged with committing to the end that the person, entity or laboratory 
and its owners or directors will be able to prepare a defense; and 

(b) Specifies the statutes and regulations alleged to have been violated. 
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfions 1265, 1 267, 1320, 1322 and 
1 326, Business and Professions Code; Section 1 1 503, Government Code; and Sec- 
fion 14123, Welfare and Institutions Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate ofCompliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operafion of law on the following 
day. 

2. Certificate ofCompliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.11. Antigen. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Section 120775, Health and Safety 
Code. 

History 

1. New secfion filed 1 1-6-96 as an emergency; operative 1 1-6-96 (Register 96, 
No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate ofCompliance as to 1 1-6-96 order transmitted to OAL 3-4-97 and 
filed 4-15-97 (Register 97, No. 16). 

3. Renumbering of former section 1029.1 1 to new secfion 1029.25 filed 8-28-97 
as an emergency; operafive 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

4. Certificate ofCompliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.13. Approved Public Health Laboratory. 

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1241 and 1288.5, 
Business and Professions Code. 

History 

1. New section filed 3-19-97; operafive 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1029.13 to new section 1029.30 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.15. Alternative Sanction. 

"Alternative sanction" means one or more of the following sanctions: 

(a) Directed plan of correction; 

(b) Civil money penalty; or 

(c) Onsite monitoring. 

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Stats. 1995, c.510, Secfion 1; and 
Section 1310, Business and Professions Code. 

History 

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Renumberine of former section 1 029. 1 5 to new section 1 029.35 and new secfion 
1029.15 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 
35). A Certificate ofCompliance must be transmitted to O^^J^ by 12-26-97 or 
emergency language will be repealed by operation of law on the following day. 

3. Certificate of Comphance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.1 7. CLIA Certificate. 

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1224, 1265, 1281 and 
1288.5, Business and Professions Code. 

History 
1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 



Page 10 



Register 2001, No. 20; 5-18-2001 



Title 17 



State Department of Health Services 



§ 1029.35 



2. Renumbering of former section 1 029. 1 7 to new section 1 029.45 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 1 2-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.19. CLIA Exempt Status. 

NoTE; Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 1 13) Section 
1(a)(6). 

History 

1 . New .section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Renumbering of former secUon 1029.19 to new section 1029.50 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.20. Antibody. 

"Antibody" means an immunoglobulin molecule that, due to its spe- 
cific amino acid sequence, reacts to the antigen that induced its synthesis 
in the cells of the lymphoid series. 

NoTK: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Section 120775, Health and Safety 
Code. 

History 

1. Renumbering of former section 1029.9 to new section 1029.20 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.23. Direct Patient Care. 

NoTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Section 1206.5, Business and Profes- 
sions Code. 

History 

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1029.23 to new section 1029.70 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 1 2-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98. No. 7). 

§1029.25. Antigen. 

"Antigen" means any viral component including, but not limited to, 
proteins and nucleic acids. 

NotE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Section 120775, Health and Safety 
Code. 

History 

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1 029.25 to new section 1029.80 and renumber- 
ing of former section 1029.1 1 to new section 1029.25 filed 8-28-97 as an emer- 
gency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance 
must be transmitted to OAL by 12-26-97 or emergency language will be re- 
pealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.27. HHS. 

Note: Authority cited: Secdon 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1202.5 and 1224, Business 
and Professions Code. 

History 

1 . New section filed 3-19-97; operative 4-18-97 (Regi.ster 97, No. 12). 

2. Renumbering of former section 1029.27 to new section 1029.85 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance mu.st be transmitted to OAL by 1 2-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 



§ 1029.30. Approved Public Health Laboratory. 

"Approved public health laboratory" means a laboratory that has been 
issued a certificate of approval by the department after its determination 
that the public health laboratory, as defined in Business and Profes.sions 
Code section 1206(a)(1 1), is in conformity with chapter 7 (commencing 
with section 1000) of part 2 of division 1 of the Health and Safety Code 
and the regulations adopted thereunder. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1241 and 1288.5. 
Business and Professions Code. 

History 

1. Renumbering and amendment of former section 1029.13 to new section 
1029.30 filed 8-28-97 as an emergency; operative 8-28^97 (Register 97, No. 
35). A Certificate of Compliance must be transmitted to OAL by 12 26 97 or 
emergency language will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 1 2-24^97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.31. Arterial Puncture. 

"Arterial puncture" means the penetration of an artery with a needle 
to withdraw blood for clinical laboratory test or examination purposes. 
NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1242, 1242.5, 1242.6. 1243. 
1246 and 1269, Business and Professions Code; and Section 120580, Health and 
Safety Code. 

History 
1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003. No. 2). For 

prior history, see Register 2001, No. 14. 

§ 1029.32. Certified Phlebotomy Technician I. 

"Certified phlebotomy technician I" means a person who has com- 
pleted the education, training, experience and examination requirements 
pursuant to Section 1034 and is certified by the department to perform 
skin punctures and venipunctures. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206. 1208, 1212. 1242, 
1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, 
Health and Safety Code. 

History 

1. New section filed 1-9-2003; operative 4^9-2003 (Register 2003, No. 2). For 
prior history, see Register 2001, No. 14. 

§ 1029.33. Certified Phlebotomy Technician II. 

"Certified phlebotomy technician 11" means a person who has com- 
pleted education, training, experience and examination requirements 
pursuant to Section 1034 and is certified by the department to perform 
skin punctures, venipunctures and arterial punctures. 
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfions 1206, 1208, 1212, 1242, 
1242.5, 1246 and 1269. Business and Professions Code; and Section 120580. 
Health and Safety Code. 

History 
1. New secdon filed 1-9-2003; operative 4-9-2003 (Register 2003. No. 2). For 

prior history, see Register 2001, No. 14. 

§1029.34. Certifying Organization. 

"Certifying organization", also called a national accreditation or ac- 
crediting board or agency, means an organization, agency or body that 
creates competency examinations that measure the skill, knowledge and 
aptitude required of an individual in a profession, occupation or disci- 
pline. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275. Health and Safety Code. Reference: Sections 1246. 1262, 1264 and 1270, 
Business and Professions Code; and Section 120580, Health and Safety Code. 

History 
1. New secdon filed 1-9-2003; operadve 4-9-2003 (Register 2003, No. 2). 

§1029.35. Chapter 3. 

"Chapter 3" means chapter 3 (commencing with section 1 200) of divi- 
sion 2 of the Business and Professions Code. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Section 1224. Business and Profes- 
sions Code. 

History 

1. New secdon filed 1 1-6-96 as an emergency; operative 1 1-6-96 (Register 96. 
No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-97 



Page 11 



Register 2003, No. 2; 1 - 1 0-2003 



§ 1029.37 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 1 1-6-96 order transmitted to OAL 3-4-97 and 
filed 4-15-97 (Register 97, No. 16). 

3. Renumbering of former section 1029.35 to new section 1 029.90 and renumber- 
ing and amendment of former section 1029.15 to new section 1029.35 filed 
8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certifi- 
cate of Compliance must be transmitted to OAL by 1 2-26-97 oremergency lan- 
guage will be repealed by operation of law on the following day. 

4. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.37. Instrument. 

NOTI;: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209 and 
1269. Business and Professions Code. 

History 

1. New section filed 3-19-97; operaUve 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1 029.37 to new section 1 029. 1 00 filed 8-28-97 
as an emergency; operative 8-28-97 (Regi.ster 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 oremergency language 
will be repealed by operation of law on the iollowing day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.39. Licensed General Acute Care Hospital. 

NoTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfions 1224 and 1265, Business 
and Professions Code. 

History 

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1 029.39 to new section 1 029 . 11 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 1 2-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.40. Civil Money Penalties. 

"Civil money penalties" means the civil money penalties imposed by 
the department under the procedures identified in section 1067.5. 
NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; and Stats. 1995, c.510, Secfion 1. Reference: 
SecUon 1310, Business and Professions Code. 

History 

1. New section filed 3-19-97; operative 4-1 8-97 (Register 97, No. 12). 

2. Renumbering of former section 1029.40 to new section 1029.115 and new sec- 
tion 1029.40 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.43. Patient. 

NoTE: Authority cited: Section 1224. Business and Professions Code; and Section 
100275, Heahhand Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 
1241 and 1269, Business and Professions Code 

History 

1. New section filed 3-19-97; operafive 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1 029.43 to new secfion 1 029. 1 30 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.44. Preceptor. 

NoTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfions 1206, 1206.5, 1209, 1220 
and 1265, Business and Professions Code. 

History 

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Renumbering of former secfion 1029.44 to new secfion 1029.135 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 1 2-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 



§1029.45. CLI A Certificate. 

"CLIA certificate" moans an unsuspended and unrevoked certificate 
of compliance, certificate for provider-performed microscopy proce- 
dures, certificate of accreditation, certificate of registration or a certifi- 
cate of waiver, as defined in 42 Code of Federal Regulations section 
493.2. 

NoTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1224, 1265. 1281 and 
1288.5. Business and Professions Code. 

History 

1. Renumberins and amendment of former section 1029.17 to new .section 
1029.45 filed V28-97 as an emergency; operative 8-28-97 (Register 97, No. 
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or 
emergency language will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.47. Respiratory Care Practitioner. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206.5 and 1265, Business 
and Professions Code. 

History 

1. New secfion filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1 029.47 to new section 1 029. 1 50 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmiued to OAL by 1 2-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98. No. 7). 

§1029.49. Specimen. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfions 1206. 1209, 1225, 1241, 
1244, 1269, 1288, 1288.5 and 1320, Business and Professions Code. 

History 

1. New secfion filed 3-19-97; operafive 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1029.49tonew section 1029.155 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 oremergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.50. CLIA Exempt Status. 

"CLIA exempt status" means that the United States Department of 
Health and Human Services (HHS) has exempted clinical laboratories li- 
censed, registered or otherwise approved by the department from the re- 
quirements of CLIA pursuant to subsection (p) of section 263a of title 42 
of the United States Code and secfion 493.5 13 of title 42 of the Code of 
Federal Regulafions. 

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 1 13) Section 
1(a)(6). 

History 

1. Renumbering and amendment of former section 1029.19 to new section 
1029.50 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or 
emergency language will be repealed by operafion of law on the following day. 

2. Cerfificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.51 . Clinical Consultant. 

"Clinical consultant" means a person who meets the requirements of 
Section 493. 1455 of Title 42, Code of Federal Regulations, as published 
October 1 , 1 994, and who provides clinical consultation of a laboratory 
in accordance with Section 1036 of this title and Section 493.1457 of 
Title 42, Code of Federal Regulations, as published October 1, 1994. 
NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfions 1203, 1204, 1207, 1209, 
1209.1 and 1210, Business and Professions Code. 

History 

1. Renumbering of former secfion 1029.31 to section 1029.51 filed 4-3-2001 ; op- 
erafive 4-3-2001 (Register 2001, No. 14). For prior histor/, see Register 98, 

No. 7. 

§1029.52. Clinical Cytogenetics. 

"Clinical cytogenetics" means the techniques used to isolate, replicate 
and identify whole or parts of human chromosomes including culturing, 



Page 12 



Register 2003, No. 2; 1-10-2003 



Title 17 



State Department of Health Services 



§ 1029.81 



• 



manipulation, banding, staining and Iiybridizing, and analysis with re- 
spect to genotype and phenotype. 

NoTIi: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275. Health'and Safety Code. Reference: Sections 1206, 1207. 1210, 1261.5 
and 1264, Business and Professions Code. 

History 
1. Renumbering of former section 1029.32 to section 1029.52 filed 4-3-2001 ; op- 
erative 4-3-2001 (Register 2001. No. 14). For prior history, see Register 98. 
No. 7. 

§ 1029.53. Clinical Genetic Molecular Biology. 

"Clinical genetic molecular biology" means the determination of all 
the aspects of molecular organizations of the nucleic acids of the human 
genome with respect to genotype and phenotype. 

NOTH: Authority cited: Section 1224. Business and Professions Code: and Section 
100275. Health and Safety Code. Reference: Sections 1206. 1207. 1210. 1261.5 
and 1264. Business and Professions Code. 

History 
1 . Renumberins of former section 1 029.33 to section 1 029.53 filed 4-3-2001 ; op- 
erative 4-3-2001 (Register 2001, No. 14). 

§ 1029.55. Condition Level Deficiency. 

"Condition level deficiency" means noncompliance with one or more 
condition level requirements. 

NOTE: Authority cited: Section 1224. Business and Professions Code: Section 
100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: 
Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code. 

History 

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1029.55 to new section 1029.185 and new sec- 
tion 1029.55 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.57. Test Purposes. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6 
and 1246. Business and Professions Code. 

History 

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1029.57 to new section 1029.1 80 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97. No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.59. Unprofessional Conduct. 

NotE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275. Health and Safety Code. Reference: Section 1320, Business and Profes- 
sions Code. 

History 

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12). 

2. Renumbering of former section 1029.59 to new section 1 029. 190 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2 9-98 (Register 98, No. 7). 

§ 1029.60. Condition Level Requirement. 

"Condition level requirement" means any of the requirements speci- 
fied in section 1066. 

NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: 
Stats. 1995. c. 510. Section 1; and Section 1310, Business and Professions Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 



§1029.65. Deficiency. 

"Deficiency" or "Violation" means noncompliance with one or more 
of the requirements in chapter 3, division 2 of the Business and Profes- 
sions Code (commencing with section 1200) or any rule or regulation 
adopted thereunder. 

NoTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code: and Stats. 1995. c. 510, Section 1. Reference: 
Stats. 1995, c. 510, Section 1 ; and Sections 1310, 1320, 1323 and 1.326, Bu.siness 
and Professions Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 1 2-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12 24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.70. Direct Patient Care. 

"Direct patient care" means medical, psychiatric, nursing or other 
health care which is legally provided by a care giver or healthcare provid- 
er directly to a patient, and wliich includes ob.servation of the patient's 
physical or mental condition to enable the care giver or healthcare pro- 
vider to report changes in the patient's condition. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Section 1 206.5, Business and Profes- 
sions Code. 

History 

1 . Renumbering of former section 1029.23 to new section 1029.70 filed 8 28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-^97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.75. Directed Plans of Correction. 

"Directed plans of correction" means the directed plans of correction 
imposed by the department under the procedures identified in section 
1067. 

NOTE: Authority cited: Section 1224. Business and Professions Code; Section 
100275, Health and Safety Code; and Stats. 1995, c. 510. Secfion 1. Reference: 
Stats. 1995, c. 510, Secfion I; and Section 1310. Business and Professions Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 1 2-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.80. Electrolytes. 

"Electrolytes" means ionized calcium, sodium, potassium and/or 
chloride. 

NOTE; Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Section 1206, Business and Profes- 
sions Code. 

History 

1. Renumbering of former section 1029.25 to new section 1029.80 filed 8 28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.81 . Evidence of Satisfactory Performance. 

"Evidence of satisfactory performance" means a copy of a document 
issued to an examinee by the department for satisfactory performance on 
a department-administered licensing written examination, or by a certi- 
fying board or organization indicating satisfactory performance by the 
examinee on a written certifying examination. 

NOTE; Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1208, 1260, 1261. 1261.5, 
1262 and 1264, Business and Professions Code. 

History 
1 . New section filed 2-24-2000 as an emergency: operative 2-24-2000 ( Register 

2000, No. 8). A Certificate of Compliance musl be transmitted to OAL by 

6-23-2000 or emergency language wiU be repealed by operation of law on the 

following day. 



Page 13 



Register 2003, No. 2; 1-10- 2003 



§ 1029.82 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



2. New section refiled 6-2 1-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10 23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 1 0-1 9-2000 as an emergency, operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 

§ 1029.82. Field Related to Genetics. 

"Field related to genetics" means a major in molecular biology, repro- 
ductive biology, biochemistry, clinical genetics, medical genetics, clini- 
cal cytogenetics, biochemical genetics, human genetics, clinical labora- 
tory science, or clinical molecular genetics. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206 and 1210, Business 
and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-1 9-2000 as an emergency; operative 10-2 4-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 

§1029.83. General Supervisor. 

"General supervisor" means a person who meets the requirements of 
Section 493. 1461 of Title 42, Code of Federal Regulations, as published 
October 1, 1994, and who provides general supervision of a laboratory 
in accordance with Section 1036.1 of this title and Section 493.1463 of 
Title 42, Code of Federal Regulations, as published October 1, 1994. 
NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 
1209.1 and 1210, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
1 0-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 1 0-1 9-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 

§1029.85. HHS. 

"HHS" means the federal Department of Health and Human Services, 
or its designee. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1202.5 and 1224, Business 
and Professions Code. 

History 

1 . Renumbering of former section 1029.27 to new section 1029.85 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.86. High Complexity Tests or Examinations. 

"High complexity tests or examinations" mean those clinical laborato- 
ry tests or examinations classified as high complexity under CLIA. 



NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1202.5, 1203. 1204, 1206, 
1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code. 

History 

1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-2 1-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-19-2000 as an emergency; operafive 10-24-2000 ( Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
secdon, transmitted to OAL 2-2 1-2001 and filed 4-3-2001 (Register 2001 , No. 
14). 

§ 1029.90. Human Immunodeficiency Virus. 

"Human Immunodeficiency Virus" or "HIV" means the etiologic vi- 
rus of Acquired Immune Deficiency Syndrome, or AIDS. 
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfion 120775, Health and Safety 
Code. 

History 

1, Renumbering of former section 1029.35 to new section 1029.90 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.95. Immediate Jeopardy. 

"Immediate jeopardy" means a situation in which immediate correc- 
tive action is necessary because the laboratory's noncompliance with one 
or more conditions has already caused, is causing, or is likely to cause, 
at any time, serious injury or harm, or death, to individuals served by the 
laboratory or to the health or safety of the general public. This term is syn- 
onymous with imminent and serious risk to human health and significant 
hazard to the public health. 

NOTE: Authority cited: Secfion 1224, Business and Professions Code; Section 
1 00275, Health and Safety Code; Stats. 1 995, c. 5 10, Section 1; and Section 14105, 
Welfare and Institufions Code. Reference: Stats. 1995, c. 510, Section 1; and Sec- 
tions 1310, 1320, 1323 and 1326, Business and Professions Code; and Section 
14123, Welfare and Institufions Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Comphance must be transmitted to OAL by 1 2-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.100. Instrument. 

"Instrument" means a device, apparatus, implement, machine or con- 
trivance that is used for the performance of a clinical laboratory test or 
examination, 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209 and 
1269, Business and Professions Code. 

History 

1. Renumbering of former section 1029.37 to new section 1029. 100 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.105. Intermediate Sanction. 

"Intermediate sanction" means either or both: 

(a) Temporary suspension of a license, registration or approval; or 

(b) Temporary suspension of a provider of service under the Medi-Cal 

program. 

NOTE: Authority cited: Secfion 1224, Business and Professions Code; Section 
100275, Health and Safety Code; and Secfion 14105, Welfai-e and Insfitutions 
Code. Reference: Stats. 1995, c. 510, Section 1; and Section 1323, Business and 



• 



Page 14 



Register 2003, No. 2; 1-10-2003 



Title 17 



State Department of Health Services 



§ 1029.119 



Professions Code; Section 1002, Health and Safety Code: Section 14123, Welfare 
and Institutions Code; 42 United States Code, Section 1393w-2 (Section 1846 of 
the federal Social Security Act); and 42 United States Code, Section 1396a(a)(9) 
(Section 1902(a)(9)(C) of the federal Social Security Act). 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.108. License. 

For the purposes of this chapter, "license" means license, certificate, 
registration or other means to engage in a business or profession regu- 
lated by Chapter 3. 

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 23.7, 1203, 1204, 1205, 
1206.5, 1207, 1208, 1209, 1210, 1220, 1227, 1242, 1246, 1246.5, 1260, 1260.1, 
1261, 1261.5, 1262, 1263, 1264, 1265, 1267, 1269.5, 1270, 1275, 1280. 1281, 
1285, 1288.5, 1300, 1301, 1301.1, 1310, 1320, 1322, 1323, 1324 and 1325, Busi- 
ness and Professions Code; and Section 120580, Health and Safety Code. 

History 
1. New section filed 1-9-2003; operadve 4-9-2003 (Register 2003, No. 2). 

§ 1029.110. Licensed General Acute Care Hospital. 

"Licensed general acute care hospital" means a facility as defined in 
section 1 250(a) of the Health and Safety Code that has been licensed pur- 
suant to chapter 2 (commencing with section 1250) of division 2 of the 
Health and Safety Code. 

NOTIi: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business 
and Professions Code. 

History 

1. Renumbering and amendment of former secfion 1029.39 to new section 
1029. 1 10 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 
35). A Certificate of Compliance must he transmitted to OAL by 12-26-97 or 
emergency language will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.1 1 1 . Licensed Healthcare Professional. 

Note: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206.5 and 1208, Business 
and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New secfion refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
1 0-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-19-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Comphance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including repealer of sec- 
tion, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 
14). 

§ 1 029.1 1 5. Licensed Surgical Clinic. 

"Licensed surgical clinic" means a facility as defined in section 
1 204(b)( 1 ) of the Health and Safety Code that has been licensed pursuant 
to chapter 1 (commencing with section 1200) of division 2 of the Health 
and Safety Code. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business 
and Professions Code. 

History 

1. Renumbering and amendment of former section 1029.40 to new section 
1 029. 1 1 5 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 
3.5). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or 
emergency language will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 



§ 1 029.1 1 6. Limited Phlebotomy Technician. 

"Limited phlebotomy technician" means a person who has completed 
the education, training and experience requirements pursuant to Section 
1034 and is certified by the department to perform skin punctures. 
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Heaith'and Safety Code. Reference: Sections 1206, 1208, 1212, 1242, 
1242.5, 1246 and 1269, Business and Professions Code; and Secfion 120580, 
Health and Safety Code. 

History 
1. New section filed 1-9-2003; operaUve 4-9-2003 (Register 2003, No. 2). 

§ 1 029.1 1 7. Medical Laboratory Technician. 

"Medical laboratory technician" means a person who has completed 
education, training or experience, and examination requirements pur- 
suant to Section 1032.5(a), and who is authorized to perform clinical lab- 
oratory tests and examinations specified in Section 1032.5(b). 
NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfions 1206, 1207, 1208, 1210. 
1242, 1260.3, 1264 and 1300, Business and Professions Code. 

History 

1. New section filed 1-13-2005 as an emergency; operafive 1-13-2005 (Register 
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by 
5-13-2005 or emergency language will be repealed by operation of law on the 
following day. 

2. New secfion refiled 5-12-2005 as an emergency; operafive 5-14-2005 (Regis- 
ter 2005, No. 19). A Certificate of Compliance must be transmitted to OAL by 
9-1 2-2005 or emergency language will be repealed by operation of law on the 
following day. 

3. Certificate of Compliance as to 5-12-2005 order transmitted to OAL 8-3-2005 
and filed 9-12-2005 (Register 2005, No. 37). 

§ 1 029.1 1 8. Moderate Complexity Laboratory Technical 
Consultant. 

"Moderate complexity laboratory technical consultant" means a per- 
son who meets the qualifications of Section 493.141 1 of Title 42, Code 
of Federal Regulations, as published October 1, 1994, and who provides 
technical oversight in accordance with Section 1036.2 of this title and 
Section 493.1413 of Title 42, Code of Federal Regulations, as published 
October 1. 1994. 

NOTE: Authority cited: Secfion 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 
1209.1 and 1210, Business and Professions Code. 

History 

1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New secfion refiled 6-21-2000 as an emergency; operafive 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New secfion refiled 10-1 9-2000 as an emergency; operafive 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 

§ 1029.119. Moderate Complexity Tests or Examinations. 

"Moderate complexity tests or examinafions" mean those clinical lab- 
oratory tests or examinations classified as moderate complexity under 
CLIA. 

NotE: Authority cited: Secfion 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1202.5, 1203, 1204, 1206, 
1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New secfion refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-19-2000 as an emergency; operative 10-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 



Page 15 



Register 2005, No. 37; 9-16-2005 



§ 1029.120 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section, transmitted to OAL 2-2 1-2001 and filed 4-3-2001 (Resister 2001 , No. 

14). 

§ 1 029.1 20. Notice of Defense. 

"Notice of Defense" means a writing signed by or on behalf of the per- 
son, entity or laboratory, stating the maiUng address of the person, entity, 
or laboratory, and may: 

(a) Request a hearing. 

(b) Object to the accusation upon the ground that it docs not state acts 
or omissions upon which the agency may proceed. 

(c) Object to the form of the accusation on the ground that it is so indef- 
inite or uncertain that the person, entity, or laboratory cannot identify the 
transaction or prepare a defense. 

(d) Admit the accusation in whole or in part. 

(e) Present new matter by way of defense. 

(f) Object to the accusation upon the ground that, under the circum- 
stances, compliance with the requirements of a regulation would result 
in material violation of another regulation enacted by another department 
affecting substantive rights. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275. Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and 
1326, Business and Professions Code; Sections 11503 and 11504, Government 
Code; and Section 14123, Welfare and Institutions Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.124. On-the-Job Experience in Phlebotomy. 

"On-the-job experience in phlebotomy" means employment as a 
phlebotomist in a clinical laboratory performing the techniques pursuant 
to Section 1035.1(f). 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6, 
1243, 1 246 and 1269, Business and Professions Code; and Section 120580, Health 
and Safety Code. 

History 

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2). 

§ 1 029.1 25. Onsite Monitoring. 

"Onsite monitoring" means the onsite monitoring imposed by the de- 
partment under the procedures identified in section 1067.10. 
NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; and Stats. 1995, c. 510, Secdon 1. Reference: 
Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code. 

History 

1. New section filed 8-28-97 as an emergency; operafive 8-28-97 (Register 97. 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.126. Oral and Maxillofacial Pathology Laboratory 
Director. 

"Oral and maxillofacial pathology laboratory director" means a den- 
tist who possesses a valid, unexpired license to direct an oral pathology 
laboratory in all areas of anatomic and clinical pathology related to the 
oral and maxillofacial region. 

Note: Authority cited: Secdon 1224, Business :ind Professions Code; and Secdon 
100275, Health and Safety Code. Reference: Secdons 1206, 1206.5, 1207, 1208 
and 1209, Business and Professions Code. 

History 

1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 



3. New section refiled 1 0-1 9-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section heading and section, transmirted to OAL 2-21-2001 and filed 
4-3-2001 (Register 2001, No. 14). 

§ 1029.127. Oral Pathology. 

"Oral pathology" means the subspecialty of pathology that deals with 
the nature, identification and management of diseases affecting the oral 
and maxillofacial regions, which investigates the causes, processes and 
effects of these diseases, and includes research and diagnosis of diseases 
using clinical, radiographic, microscopic, biochemical or other examina- 
tions. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206 and 1207, Business 
and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operadve 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New secdon refiled 1 0-1 9-2000 as an emergency; operadve 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Cerdficate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 

§1029.130. Patient. 

"Patient" means a person who is an inpatient or outpatient of a licensed 
health facility, licensed clinic or a clinic that is exempt from Hcensure, 
licensed home health agency, or who is a patient of a h censed physician 
and surgeon or osteopath, licensed dentist, or licensed podiatrist. 
Note-. Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secdons 1206, 1206.5, 1209, 1220, 
1241 and 1269, Business and Professions Code. 

History 

1 . Renumbering of former section 1029.43 to new section 1029.130 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.132. Phlebotomist. 

"Phlebotomist" means a person who collects blood for clinical labora- 
tory test or examination purposes. 

Note: Authority cited: Secdon 1224, Business and Professions Code; and Secdon 
100275, Health and Safety Code. Reference: Secdons 1206, 1208, 1212, 1242, 
1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, 
Health and Safety Code. 

History 

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2). 

§1029.133. Phlebotomy. 

"Phlebotomy" means the process of collecting blood by venipuncture, 
arterial puncture or skin puncture for the purpose of obtaining blood for 
clinical laboratory test or examination purposes. 

Note: Authority cited: Secdon 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secdons 1206, 1242, 1242.5, 1246 
and 1269, Business and Professions Code; and Secdon 120580, Health and Safety 
Code. 

History 
I. New secdon filed 1-9-2003; operadve 4-9-2003 (Register 2003, No. 2). 

§ 1029.134. Practical Experience. 

"Practical experience" means hands-on, direct work experience in 
clinical laboratory science and phlebotomy techniques on real patients in 
a clinical laboratory certified by CLIA, using equipment, instruments, 
kits and materials routinely found in clinical laboratories performing 
moderate or high complexity tests or examinations, and does not include 



Page 16 



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Title 17 



State Department of Health Services 



§ 1029.135 



work done in academic, research, forensic, pharmaceutical or veterinary 

laboratories. 

NoTli: Authority cited: Section 1224, Business and Professions Code; and Section 

100275. Health and Safety Code. Reference: Sections 1206, 1208, 1222.5, 1242, 

1242..5. 1243, 1246, 1260, 1260.3, 1261, 1261.5, 1264, 1269 and 1286. Business 

and Professions Code. 

History 

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register 
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by 
5-1.3-2005 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Regis- 
ter 2005, No. 19). A Certificate of Compliance must be transinitted to OAL by 
9-12-2005 or emergency language will be repealed by operation of law on the 
following day. 

3. Certificate of CompUance as to 5-12-2005 order, including amendments, trans- 
mitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37). 

§1029.135. Preceptor. 

"Preceptor" means: 

(a) The laboratory director or the technical consultant of the laborato- 
ry, as that term is defined under CLIA; or, 



(b) A person who: 

( 1 ) Meets the qualifications of a technical consultant under CLIA and 
of chapter 3 to perform clinical laboratory tests or examinations classi- 
fied as of moderate complexity; and, 

(2) Is assigned by the laboratory director or the technical consultant of 
the laboratory to act as a preceptor; or, 

(c) Any person listed in subdivision (b) of section 1206.5 of the Busi- 
ness and Professions Code, except for those persons listed in subsections 
(10), (II), or (12) of subdivision (b), and who: 

( 1 ) Has two years of experience performing moderate complexity tests 
upon the instrument(s) for which she or he will act as a preceptor; and 

(2) Meets any CLIA requirements necessary to perform his or her du- 
ties and responsibilities in a preceptor program; and 

(3) Is assigned by the laboratory director or the technical consultant of 
the laboratory to act as a preceptor. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1206.5. 1209. 1220 
and 1265, Business and Professions Code. 



[The next page is 17.] 



Page 16.1 



Register 2005, No. 37; 9-16-2005 



Title 17 



State Department of Health Services 



§ 1029.168 



History 

1. Renumbering and amendment of former section 1029.44 (o new section 
1029. 135 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 
?>5). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or 
emergency language will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.140. Principal Sanction. 

"Principal sanction" means: 

(a) Suspension or revocation of a registration or license issued under 
chapter 3 of division 2 of the Business and Professions Code; or 

(b) Suspension or revocation of the approval to operate a public health 
laboratory granted under chapter 7 (commencing with section 1000) of 
the Health and Safety Code; or 

(c) Suspension of a provider of service from further participation in. 
including reimbursement from, the Medi-Cal and Medicaid programs. 
NoTIi: Authority cited: SecUon 1224, Business and Professions Code; Section 
100275, Health and Safety Code; Stats. 1 995, c. 5 10, SecUon 1; and Section 14105, 
Welfare and Insdtutions Code. Reference: Stats. 1995, c. 510, Section 1; Sections 
1320 and 1322, Business and Professions Code; Section 1002, Health and Safety 
Code; and Section 14123, Welfare and Institutions Code. 

History 

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transinitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.1 45. Provider of Service. 

"Provider of service" has the same meaning as given in 22 CCR 5 1 05 1 . 

NOTE; Authority cited: Section 1224, Business and Professions Code; Section 
100275. Health and Safety Code; Stats. 1995, c. 510, Section Land Section 14105, 
Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section I ; and Sec- 
tion 14123, Welfare and Institutions Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.150. Respiratory Care Practitioner. 

"Respiratory care practitioner" means an individual licensed pursuant 
to chapter 8.3 (commencing with section 3700) of division 2 of the Busi- 
ness and Professions Code. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206.5 and 1265, Business 
and Professions Code. 

History 

1. Renumbering and amendment of former section 1029.47 to new section 
1 029. 1 50 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or 
emergency language will be repealed by operation of law on the following day. 

2. Editorial correction (Register 98, No. 7). 

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.153. Satisfactory Performance. 

"Satisfactory performance" means achieving at least the minimum 
grade that an examinee must obtain to get a passing score on a written or 
oral examination. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1208, 1260, 1261, 1261.5, 
1262 and 1264, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
1 0-23-2000 or emergency language will be repealed by operation of law on the 
following day. 



3. New section refiled 10-19-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 

§ 1 029.1 54. Skin Puncture. 

"Skin puncture" means penetration of the .skin for the purpose of col- 
lecting capillary blood for clinical laboratory test or examination pur- 
poses. 

NOTE; Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206. 1242, 1242.5. 1246 
and 1269, Business and Professions Code; and Section 120580, Health and Safet} 
Code. 

History 
1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003. No. 2). 

§1029.155. Specimen. 

"Specimen" has the same meaning as given for "biological specimen" 
in section 1206(a)(1) of the Business and Professions Code. 
NOTE; Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1209, 1225. 1241. 
1244, 1269, 1288, 1288.5 and 1320, Business and Professions Code. 

History 

1. Renumbering and amendment of former section 1029.49 to new section 
1029.155 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or 
emergency language will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.1 60. State License. 

"State license" or "license" means the license identified in section 
1265(a)(1) of the Business and Professions Code. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1265, 1281 and 1288.5, 
Business and Professions Code. 

History 

1. Renumbering and amendment of former section 1029.51 to new section 
1029.160 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97. No. 
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or 
emergency language will be repealed by operation of law on the following day. 

2. Certificate of Comphance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.1 65. State Registration. 

"State registration" or "registration" means the registration identified 
in section 1265(a)(2) of the Business and Professions Code. 
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1265, 1281 and 1288.5, 
Business and Professions Code. 

History 

1. Renumbering and amendment of former secdon 1029.52 to new section 
1029. 165 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or 
emergency language will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.1 68. Statement of Issues. 

"Statement of issues" means a written statement served on the person, 
entity or laboratory which: 

(a) Specifies the statutes and regulations with which the person, entity 
or laboratory must show compliance by producing proof at the hearing, 
and 

(b) Includes any particular matters which have come to the attention 
of the department that could form the basis for a denial of the departmen- 
tal action sought. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1265, 1267. 1320. 1322 and 
1326, Business and Professions Code; Sections 11503 and 11504, Government 
Code; and Section I4I23, Welfare and Institutions Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97. 
No. 35). A Certificate of Compliance must be transmitted to OAL by 1 2-26-97 



Page 17 



Register 2003, No. 2; 1-10-2003 



§ 1029.169 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 ordei , including amendment of subsec- 
tion (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7). 



§ 1 029.1 69. Subspecialty of Histocompatibility. 

"Subspecialty of histocompatibility" means those clinical laboratory 
analyses of factors that determine the acceptance or rejection of grafted 
tissues or organs and that are performed in a histocompatibility laborato- 
ry as specified in Section 493.1265 of Title 42, Code of Federal Regula- 
tions, as published October 1, 1994. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275. Health and Safety Code. Reference: .Sections 1206, 1209.1 and 1210, 
Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
1 0-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10- 19-2000 as an emergency; operative 10-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transiiutted to OAL 
by 2-2 1-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 
14). 



§ 1 029.1 70. Temporary Suspension of a License, 
Registration or Approval. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Sec- 
tions 1002 and 100275, Health and Safety Code. Reference: Stats. 1995, c. 510, 
Section l;Section 1323, Business and Professions Code; and Section 1002, Health 
and Safety Code. 

History 

1. New secdon filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

3. Change without regulatory effect renumbering former section 1029. 1 70 to sec- 
tion 1029. 173 filed 5-14-2001 pursuant to section 100, title 1 , CaUfornia Code 
of Regulations (Register 2001, No. 20). 



§ 1 029.1 71 . Technical Supervisor. 

"Technical supervisor" means a person who meets the qualifications 
of Section 493.1449 of Title 42, Code of Federal Regulations, as pub- 
lished October 1 , 1 994, and who provides technical supervision in accor- 
dance with Section 1036.4 of this title and Section 493.1451 of Title 42, 
Code of Federal Regulations, as published October 1, 1994. 
NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section 
100275. Health and Safety Code. Reference: Secfions 1203, 1204, 1207, 1209, 
1209.1 and 1210, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-2 1-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
] 0-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-1 9-2000 as an emergency; operative 10-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. . 

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 



§ 1 029.1 73. Temporary Suspension of a License, 
Registration or Approval. 

"Temporary suspension of a license, registration or approval" means 
immediate suspension or limitation of a public health laboratory's ap- 
proval to perform testing or a clinical laboratory's license or registration 
to perform tests or examinations in one or more, or all, specialties or sub- 
specialties, prior to a hearing, based on a departmental finding of imme- 
diate jeopardy. 

NOTE: Authority cited: Section 1224, Business and Professions Code: and Sec- 
tions 1002 and 100275, Health and Safety Code. Reference: Stats. 1995, c. 510, 
Section 1 ; Secfion 1 323. Business and Professions Code; and Secfion 1002, Health 
and Safety Code. 

History 
1 . Change without regulatory effect renumbering former secfion 1 029. 1 70 to sec- 
tion 1029.173 filed 5-14-2001 pursuant to section 100, title 1 , California Code 
of Regulations (Register 2001, No. 20). 

§ 1 029.1 75. Temporary Suspension of a Provider of 
Service Under the Medi-Cal Program. 

"Temporary suspension of a provider of service under the Medi-Cal 
program" means the immediate suspension imposed by the department 
pursuant to 22 CCR 51529(g) under the procedures identified in section 
1067.15. 

NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; and Secfion 14105, Welfare and Institutions 
Code. Reference: Stats. 1995, c. 510, Secfion 1; Section 14123, Welfare and Insfi- 
tutions Code; 42 United States Code; Secfion 1395w-2 (Secfion 1846 of the feder- 
al Social Security Act); and 42 United States Code, Secfion 1396a(a)(9) (Section 
1902(a)(9)(C) of the federal Social Security Act). 

History 

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.1 80. Test Purposes. 

"Test purposes," as it relates to arterial puncture, venipuncture, and 
skin puncture, means withdrawal, or injection of any test materials spe- 
cifically required for a clinical laboratory test, provided that appropriate 
instructions relative to injection technique have been given and that a li- 
censed physician and surgeon is immediately available when test materi- 
als are injected. Unlicensed personnel may not inject test material for any 
purpose. 

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfions 1206, 1242, 1242.5, 1242.6 
and 1246, Business and Professions Code. 

History 

1 . Renumbering of former secfion 1 029.57 to new secfion 1 029. 1 80 filed 8-28-97 
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of 
CompUance must be transmitted to OAL by 1 2-26-97 or emergency language 
will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1 029.1 85. Testing Event. 

"Testing evenf means the performance of the preanalytical, analyti- 
cal, and postanalytical activities related to performing a clinical laborato- 
ry test or examination on a biological specimen. 

NOTE: Authority cited: Secfion 1 224, Business and Professions Code; and Secfion 
100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 
1241, 1244, 1265, 1281, 1288.5 and 1300, Business and Professions Code. 

History 

1 . Renumbering of former section 1029.55 to new secfion 1029.185 filed 8-28-97 
as an emergency; operafive 8-28-97 (Register 97, No. 35). A Certificate of 
Compliance must be transmitted to OAL by 12-26-97 or emergency language 
will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1029.190. Unprofessional Conduct. 

"Unprofessional conduct," pursuant to the provisions of Section 
1320(m), Business and Professions Code, means: 



Page 18 



Register 2003, No. 2; 1-10-2003 



Title 17 



State Department of Health Services 



§ 1030.5 



(a) Acts of gross negligence in the performance of duties authorized 
by the license under chapter 3, division 2, Business and Professions 
Code. 

(b) Acts of gross incompetence in the performance of duties autho- 
rized by the license under chapter 3, division 2, Business and Professions 
Code. 

NOTH: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Section 1320, Business and Profes- 
sions Code. 

History 

1. Renumbering and amendment of former section 1029.59 to new section 
1029. 190 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or 
emergency language will be repealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1029.195. Venipuncture. 

"Venipuncture" means the penetration of a vein with a needle to with- 
draw blood for clinical laboratory test or examination purposes. 
NOTH: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1246 
and 1269, Business and Professions Code; and Section 120580, Health and Safety 
Code. 

History 
1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2). 

§ 1 029.1 96. Waived Laboratory Supervisor. 

"Waived laboratory supervisor" means a person who meets the quali- 
fications specified in Section 1036.3(a) or (c) and provides technical 
oversight of a laboratory only performing waived tests. 
NOTE: Authority cited: Sections 1208 and 1224, Business and Professions Code; 
and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 
1207. 1208, 1209, 1209.1 and 1210. Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
1 0-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 1 0-1 9-2000 as an emergency; operative 10-24—2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section heading and section, transmitted to OAL 2-21-2001 and filed 
4-3-2001 (Register 2001, No. 14). 

§ 1 029.1 97. Waived Tests. 

"Waived tests" mean those clinical laboratory tests or examinations 
classified as waived under CLIA. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1202.5, 1203. 1204, 1206, 
1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
1 0-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 1 0-1 9-2000 as an emergency; operative 10-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-2 1-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 
14). 



Article 1.5. Licensure of Clinical Laboratory 
Personnel 

§ 1030. Examination for Bioanalysts' Licenses. 

(a) The examination for license as a clinical laboratory bioanalyst shall 
consist of three sections; namely, written, oral, and practical. The sub- 
jects covered in this examination shall have to do with the technical pro- 
cedures performed in clinical laboratories for the purpose of obtaining 
scientific data which may be used to ascertain the presence, progress, and 
source of disease. 

(b) An official transcript of college or university training shall be fur- 
nished by each applicant. The college or university training shall include 
as a minimum the indicated number of semester or equivalent quarter 
units of standard resident courses or their subject equivalent as follows: 

General inorganic chemistry 8 

Quantitative analysis 3 

Organic chemistry 3 

Biochemistry 8 

Bacteriology 8 

Physics 3 

Biology or zoology 4 

Physiology 3 

Parasitology 3 

Hematology 2 

NOTE: Authority cited for Group 2: Section 208, Health and Safety Code, and Sec- 
tions 1220 through 1223, Business and Professions Code. Additional authority 
cited: Section 102, Health and Safety Code. 

History 

1. Originally pubhshed 8-15-45 (Title 17). 

2. Revision filed 12-24-47 (Register 10, No. 8). 

3. Repealer and new Group 2 filed 12-26-51; effective thirtieth day thereafter 
(Register 26, No. 7). 

4. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 
18). 

5. New article 1.5 heading (containing secfions 1030-1034.2) filed 1 1-6-96 as an 
emergency; operative 11-6-96 (Register 96, No. 45). A Certificate of Com- 
pliance must be transmitted to OAL by 3-5-97 or emergency language will be 
repealed by operadon of law on the following day. 

6. Certificate of Compliance as to 1 1-6-96 order transmitted to OAL 3-^97 and 
filed 4-15-97 (Register 97, No. 16). 

7. Amendment of article heading filed 2-24-2000 as an emergency; operative 
2-24-2000 (Register 2000, No. 8). A Certificate of Compliance must be trans- 
mitted to OAL by 6-23-2000 or emergency language will be repealed by opera- 
tion of law on the following day. 

8. Amendment of article heading refiled 6-21-2000 as an emergency; operative 
6-24-2000 (Register 2000, No. 25). A Certificate of Compliance must be trans- 
mitted to OAL by 10-23-2000 or emergency language will be repealed by op- 
eration of law on the following day. 

9. Amendment of article heading refiled 10-19-2000 as an emergency; operative 
10-24-2000 (Register 2000, No. 42). A Certificate of Compliance must be 
transmitted to OAL by 2-21-2001 or emergency language will be repealed by 
operation of law on the following day. 

10. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 

§ 1030.5. Licensure of Clinical Chemists, Clinical 

Microbiologists, Clinical Toxicologists, Clinical 
Genetic Molecular Biologists and Clinical 
Cytogeneticists. 

A written and oral examination shall be given to each applicant for li- 
censure as a clinical chemist, clinical microbiologist, clinical loxicolo- 
gist, clinical genetic molecular biologist or clinical cytogeneticist. In ad- 
dition to the requirements for licensure as specified in Section 1 264 of the 
Business and Professions Code, an applicant shall have completed one 
year of training as a licensed trainee or equivalent in his or her specialty 
or subspecialty pursuant to Section 1207 of the Business and Professions 
Code. Also, each applicant shall have completed three years of experi- 
ence in his or her specialty pursuant to Section 1210 of the Business and 
Professions Code in a clinical laboratory thai possesses a certificate is- 
sued under CLIA for performing high complexity testing in that special- 
ty, two years of which shall have been at a supervisory level. 



Page 19 



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§ 1030.6 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



NOTE; Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Healtii and Safety Code. Reference: Sections 1204, 1205, 1207, 1210, 
1264 and 1265, Business and Professions Code. 

History 

1 . New section filed 1 1-25-70 as procedural and organizational; designated effec- 
tive 1 1-24-70 (Register 70, No. 48). 

2. Certificate of Compliance— Sec. 1 1422.1, Gov. Code, filed 1-20-71 (Register 

71, No. 4). 

3. Amendment of section heading, section and Noth tiled 2-24-2000 as an emer- 
gency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Com- 
pliance must be transmitted to OAL by 6-23-2000 or emergency language will 
be repealed by operation of law on the following day. 

4. Amendment of section heading, section ami NoTl-; refiled 6-21-2000 as an 
emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of 
Compliance must be transmitted to OAL by 10-23-2000 or emergency lan- 
guage will be repealed by operation of law on the following day. 

5. Amendment of section heading, section and NoTi: refiled 10-19-2000 as an 
emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of 
Compliance must be transmitted to OAL by 2-21-2001 or emergency language 
will be repealed by operation of law on the following day. 

6. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section.transmittedtoOAL2-21-2001 and filed 4-3-2001 (Register 2001, No. 
14). 



§ 1 030.6. Licensure of Clinical Cytogeneticists. 

(a) Except for a clinical laboratory bioanalyst licensed by the depart- 
ment who meets the laboratory director qualifications for high complex- 
ity testing in Section 493.1443 of Title 42, Code of Federal Regulations, 
as published October, 1 994, or a pathologist who meets the laboratory di- 
rector qualifications in Section 493.1443(b)(1) of Title 42, Code of Fed- 
eral Regulations, as published October 1, 1994, a laboratory director of 
a clinical laboratory that performs tests or examinations in the subspe- 
cialty of clinical cytogenetics within the specialty of genetics shall pos- 
sess a valid clinical cytogeneticist license issued by the department. , 

(b) In order to be eligible for licensure as a clinical cytogeneticist, an 
applicant shall: 

( 1 ) Be a physician and surgeon licensed by the State to practice medi- 
cine pursuant to Chapter 5 of the Business and Professions Code, and 
have: 

(A) Two years' training in clinical cytogenetics in a training program 
approved by the American Board of Medical Genetics (ABMG) or the 
Canadian Council of Medical Genetics (CCMG), and approved by the 
department pursuant to Section 1286, Business and Professions Code, 
Chapter 3, and 

(B) Two years' experience directing or supervising high complexity 
testing in the specialty of genetics in a clinical laboratory that possesses 
a certificate issued under CLIA for performing high complexity testing; 
and 

(C) Evidence of satisfactory performance on a written examination in 
clinical cytogenetics administered by the ABMG, CCMG or the depart- 
ment; and 

(D) Demonstrated satisfactory performance on an oral examination re- 
garding Business and Professions Code, C'hapter 3, and Title 42, CFR, 
Part 493, as published October 1, 1994; or 

(2) Hold an earned doctoral degree in a biological science or field re- 
lated to genetics from an accredited university with tliirty semester or 
equivalent quarter hours of post-baccalaureate course credit in genetics 
posted on an official transcript from the university registrar; and 

(A) Have two years' training in clinical cytogenetics in a training pro- 
gram approved by the ABMG or the CCMG, and approved by the depart- 
ment pursuant to Section 1286, Chapter 3. of Business and Professions 
Code; and 

(B) Have two years' experience supervising or performing clinical 
laboratory tests or examinations in clinical cytogenetics in a clinical lab- 
oratory that possesses a certificate issued under CLIA for performing 
high complexity testing; and 

(C) Provide evidence of satisfactory performance on a written ex- 
amination in clinical cytogenetics administered by the ABMG, CCMG 
or the department; and 



(D) Have demonstrated satisfactory performance on the oral examina- 
tion administered by the Department regarding Business and Professions 
Code, Chapter 3, and Title 42 Code of Federal Regulations, Part 493, as 
published October 1, 1994; or 

(3) Have served as a laboratory director of a clinical laboratory per- 
forming laboratory tests limited to the subspecialty of cytogenetics on or 
before December 31, 1997 and either; 

(A) Meet the laboratory director qualifications of Section 
493.1443(b)(2) or (b)(3) of Title 42. Code of Federal Regulations, as 
published October 1, 1994; or 

(B) Hold an earned doctoral degree, have four years' clinical cytoge- 
netics training or experience in a clinical laboratory certified by HCFA 
in clinical cytogenetics, and provide evidence of satisfactory perfor- 
mance on a written certifying examination in cytogenetics administered 
by the ABMG or the CCMG. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1207, 1209, 1264, 1265 and 
1282, Business and Professions Code. 

History 

1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operafive 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 1 0-19-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
subsections (b)( 1 )(B) and (b)(2)(B), transmitted to OAL 2-21-2001 and filed 
4-3-2001 (Register 2001, No. 14). 

§ 1030.7. Licensure of Clinical Genetic Molecular 
Biologists. 

(a) Except for a clinical laboratory bioanalyst licensed by the depart- 
ment pursuant to Business and Professions Code, Chapter 3, who meets 
the laboratory director qualifications for high complexity testing in Sec- 
tion 493. 1443 of Title 42, Code of Federal Regulations, as published Oc- 
tober, 1994, and a pathologist who meets the laboratory director qualifi- 
cations in Section 493. 1443 of Title 42, Code of Federal Regulations, as 
published October 1 , 1 994, a laboratory director of a clinical laboratory 
that performs tests or examinations in the subspecialty of molecular biol- 
ogy related to the diagnosis of abnormalities related to human genetic 
disorders shall possess a valid clinical genetic molecular biologist license 
issued by the department. 

(b) In order to be eligible for licensure as a clinical genetic molecular 
biologist, an applicant shall: 

( 1 ) Be a physician and surgeon licensed by the State, pursuant to Chap- 
ter 5 of the Business and Professions Code, to practice medicine and 
have: 

(A) Two years of training in clinical genetic molecular biology in a 
training program approved by the American Board of Medical Genetics 
(ABMG) or the Canadian Council of Medical Genetics (CCMG), and ap- 
proved by the department pursuant to Section 1286, Chapter 3 of the 
Business and Professions Code; and 

(B) Two years' experience directing or supervising high complexity 
testing in the specialty of genetics in a clinical laboratory that possesses 
a certificate issued under CLIA for performing high complexity testing; 
and 

(C) Evidence of satisfactory performance on a written examination in 
genetic molecular biology administered by the ABMG or CCMG or the 
department; and 

(D) Demonstrated satisfactory performance on an oral examination 
administered by the department regarding Chapter 3 of the Business and 
Professions Code and Part 493 of Title 42, Code of Federal Regulations, 
as published October 1, 1994; or 



Page 20 



Register 2003, No. 2; 1-10-2003 



Title 17 



State Department of Health Services 



§1031 



(2) Hold an earned doctoral degree in a biological science or field re- 
lated to genetics from an accredited university with 30 semester or equiv- 
alent quarter hours of post-baccalaureate course credit in genetics posted 
on an official transcript from the university registrar; and 

(A) Have two years' training in clinical genetic molecular biology in 
a training program approved by the ABMG or the CCMG, and approved 
by the department pursuant to Section 1286, Chapter 3 of Business and 
Professions Code; and 

(B) Have two years" experience supervising or performing clinical 
laboratory tests or examinations in clinical genetic molecular biology in 
a clinical laboratory that possesses a certificate issued under CLIA for 
performing high complexity testing; and 

(C) Provide evidence of satisfactory performance on a written certify- 
ing examination in genetic molecular biology administered by the 
ABMG or CCMG or the department; and 

(D) Have demonstrated satisfactory performance in the oral examina- 
tion regarding Chapter 3 of Business and Professions Code and Part 493 
of Title 42 Code of Federal Regulations as published October 1, 1994; 
or 

(3) Have served as a laboratory director of a clinical laboratory per- 
forming laboratory tests limited to the subspecialty of molecular biology 
related to the diagnosis of human genetic abnormalities on or before De- 
cember 31,1 997, and either: 

(A) Meet the qualifications of Section 493.1443(a), (b)(2), or (b)(3) of 
Title 42, Code of Federal Regulations, as published October 1, 1994; or 

(B) Hold an earned doctoral degree, have four years' clinical genetic 
molecular biology training or experience in a clinical laboratory that pos- 
sesses a certificate issued under CLIA for performing high complexity 
testing in the subspecialty of molecular biology, and provide evidence of 
satisfactory performance on a written certifying examination in genetic 
molecular biology administered by the ABMG or CCMG. 

NOTl-.: Authority cited: Section 1224. Business and Professions Code; and Section 
100275. Health and Safety Code. Reference: Sections 1207, 1209, 1264, 1265 and 
1282, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Comphance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-2 1-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-19-2000 as an emergency; operative 10-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-2 1-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section, transmitted to OAL 2-2 1-2001 and filed 4-3-2001 (Register 2001 , No. 
14). 



§ 1030.8. Licensure of Oral Pathology Laboratory 
Directors. 

(a) Except for a pathologist who meets the laboratory director qualifi- 
cations of Section 493.1443(b)(1) of Title 42, Code of Federal Regula- 
tions, as published October 1, 1994, a laboratory director of an oral 
pathology laboratory shall possess a valid oral pathology laboratory di- 
rector license issued by the department. 

(b) In order to be eligible for licensure as an oral pathology laboratory 
director, an applicant shall: 

( 1 ) Be a doctor of dental surgery licensed by the State pursuant to 
Chapter 4 of the Business and Professions Code to practice dentistry, and 
have: 

(A) Advanced training in oral and maxillofacial pathology in a training 
program approved by the American Dental Association (ADA) Commit- 
tee on Accreditation of Dental and Dental Auxiliary Education Programs 
in an educational institution; and 



(B) Full time experience in oral pathology which, together with ad- 
vanced training approved by the ADA, shall total a minimum of four 
years; and 

(C) Evidence of satisfactory performance on the oral pathologist certi- 
fication examination administered by the American Board of Oral 
Pathology (ABOP); and 

(D) Demonstrated satisfactory performance on an oral (verbal) ex- 
amination administered by the department regarding Chapter 3 of the 
Business and Professions Code and Title 42. Code of Federal Regula- 
tions, Part 493 as published October 1,1994; or 

(2) Have served as a laboratory director of an oral pathology laborato- 
ry on or before January 1 , 1 996, and be a doctor of dental surgery licensed 
by the State pursuant to Chapter 4 of the Business and Professions Code 
to practice dentistry, and provide evidence of satisfactory performance 
on a certifying examination in oral and maxillofacial pathology adminis- 
tered by the ABOP. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275. Health and Safety Code. Reference: Sections 1206, 1206.5, 1207, 1208, 
1209 and 1264, Business and Profession Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transinitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency: operative 6-24-2000 ( Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-1 9-2000 as an emergency; operative 1 0-24-2000 ( Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transinitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section heading and section, transmitted to OAL 2-21-2001 and filed 
4-3-2001 (Register 2001, No. 14). 

§ 1 031 . Licensure of Clinical Laboratory Specialists. 

(a) The minimum requirements for admission to the limited scientist 
examinations shall be as follows: 

( 1 ) An applicant for admission to the examination for a clinical chem- 
ist scientist license shall meet both of the following requirements: 

(A) Hold a baccalaureate or higher degree in chemistry or equivalent 
major which shall include at least 25 semester or 38 quarter units in chem- 
istry including courses in analytical chemistry and instrumentation. This 
coursework shall be verified by an official transcript showing college or 
university courses, training and degree posted by an accredited college 
or university; and 

(B) Have completed one year of post-baccalaureate training or experi- 
ence in all areas of the specialty of chemistry, as listed in (b)(1) below, 
in a clinical laboratory that possesses a certificate issued under CLIA for 
performing high complexity testing in the specialty of chemistry. 

(2) An applicant for admission to the examination for a clinical micro- 
biologist scientist shall meet both of the following requirements: 

(A) Hold a baccalaureate or higher degree in microbiology or an 
equivalent major which shall include at least 25 semester or 38 quarter 
units in microbiology including courses in medical or pathogenic micro- 
biology or bacteriology. This coursework shall be verified by an official 
transcript showing college or university courses, training and degree 
posted by an accredited college or university; and 

(B) Have completed one year of post-baccalaureate training or experi- 
ence in all areas of the specialty of microbiology, as listed in (b)(2) below, 
in a clinical laboratory that possesses a certificate issued under CLIA for 
performing high complexity testing in the specialty of microbiology. 

(3) An applicant for admission to the examination for a clinical immu- 
nohematologist scientist license shall meet both of the following require- 
ments: 

(A) Hold a baccalaureate or higher degree in biology, clinical labora- 
tory science or equivalent major which shall include at least 25 semester 
or 38 quarter units in biology, including genetics and immunology. This 
coursework shall be verified by an official transcript showing college or 



Page 20.1 



Register 2003, No. 34; 8-22-2003 



§ 1031.1 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



university courses, training and degree posted by an accredited college 
or university; and 

(B) Have completed one year of post-baccalaureate training or experi- 
ence in all areas of the specialty of immunohematology, as listed in (b)(3) 
below, in a clinical laboratory that possesses a certificate issued under 
CLIA for performing high complexity testing in the specialty of immu- 
nohematology. 

(4) An applicant for admission to the examination for clinical toxicolo- 
gist scientist license shall meet both of the following requirements: 

(A) Hold a baccalaureate or higher degree in chemistry or equivalent 
major which shall include at least 25 semester or 38 quarter units in chem- 
istry including analytical chemistry or quantitative analysis. This course- 
work shall be verified by an official transcript showing college or univer- 
sity courses, training and degree posted by a college or university from 
an accredited college or university; and 

(B) Have completed one year of post-baccalaureate training or experi- 
ence in the specialty of toxicology, as specified in (b)(4) below, in a clini- 
cal laboratory that possesses a certificate issued under CLIA for perform- 
ing high complexity testing in the subspecialty of toxicology. 

(5) An applicant for admission to the examination for a clinical he- 
matologist scientist hcense shall meet both of the following require- 
ments: 

(A) Hold a baccalaureate degree from an accredited college or univer- 
sity in biology, clinical laboratory science or an equivalent major which 
shall include at least 25 semester or 38 quarter units in biology, including 
hematology. This coursework shall be verified by an official transcript 
showing college or university courses, training and degree posted by an 
accredited college or university; and 

(B) Have one year of post-baccalaureate training or experience in all 
areas of the specialty of hematology, as specified in (b)(5) below, in a 
clinical laboratory that possesses a certificate issued under CLIA for per- 
forming high complexity testing in the specialty of hematology. 

(b) Any license issued under this section shall specify the particular 
specialty or subspecialty in which the licentiate may perform tests under 
such license. A license issued for: 

( 1 ) A clinical chemist scientist shall specify that the Ucentiate is autho- 
rized to perform clinical laboratory tests or examinations classified as 
high complexity under CLIA in the specialty or subspecialties of chemis- 
try, including routine chemistry, clinical microscopy, endocrinology and 
toxicology; immunology, including diagnostic immunology and syphilis 
serology; and molecular biology. 

(2) A clinical microbiologist scientist shall specify that the licentiate 
is authorized to perform clinical laboratory tests or examinations classi- 
fied as high complexity under CLIA in the specialty or subspecialties of 
microbiology including bacteriology, mycobacteriology, mycology, 
parasitology, and virology; immunology, including diagnostic immunol- 
ogy and syphilis serology; and molecular biology. 

(3) A clinical immunohematologist scientist shall specify that the li- 
centiate is authorized to perform clinical laboratory tests or examinations 
classified as high complexity under CLIA limited to the specialty of im- 
munohematology including ABO/Rh Type or Group, unexpected anti- 
body detection, compatibility testing and antibody identification. 

(4) A clinical toxicologist scientist shall specify that the licentiate is 
authorized to perform clinical laboratory tests or examinations classified 
as high complexity under CLIA limited to the subspecialty of toxicology. 

(5) A clinical hematologist scientist shall specify that the Hcentiate is 

authorized to perform clinical laboratory tests or examinations classified 

as high complexity under CLIA limited to the specialty of hematology 

including routine hematology and coagulation. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Healthand Safety Code. Reference Sections 1206, 1206.5, 1209, 1209.1, 
1210 and 1261, Business and Professions Code. 

History 

1. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 
18). 

2. Amendment filed 6-13-69; effective thirtieth day thereafter (Register 69, No. 

24). 



3. Amendment filed 1 1-25-70 as procedural and organizational; designated effec- 
tive 1 1 -24-70 (Register 70, No. 48). 

4. Certificate of Comphance— Sec. 1 1422.1, Gov. Code, filed 1-20-71 (Register 
71. No. 4). 

5. Amendment of section heading, section and Note filed 2-24-2000 as an emer- 
gency: operative 2-24-2000 "(Register 2000, No. 8). A Certificate of Com- 
pliance must be transmitted to OAL by 6-23-2000 or emergency language will 
be repealed by operation of law on the following day. 

6. Amendment of section heading, section and NoTi-, refiled 6-21-2000 as an 
emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of 
Compliance must be transmitted to OAL by 10-23-2000 or emergency lan- 
guage will be repealed by operation of law on the following day. 

7. Amendment of section heading, section and Note refiled 10-19-2000 as an 
emergency: operative 10-24-2000 (Register 2000, No. 42). A Certificate of 
Compliance must be transmitted to OAL by 2-2 1-2001 or emergency language 
will be repealed by operation of law on the following day, 

8. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section, transmitted to OAL 2-2 1-2001 and filed 4-3-2001 (Register 2001, No. 
14). 

§ 1 031 .1 . Licensure of Clinical Histocompatibility 
Scientists. 

(a) Each person performing high complexity laboratory tests or ex- 
aminations in the subspecialty of histocompatibility in a licensed clinical 
laboratory shall possess a valid clinical histocompatibility scientist li- 
cense except for the following persons: 

( 1 ) A physician and surgeon licensed by the State to practice medicine 
pursuant to chapter 5 of the Business and Professions Code; or 

(2) A histocompatibility laboratory director licensed pursuant to chap- 
ter 3 of the Business and Professions Code; or 

(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3 of 
the Business and Professions Code; or 

(4) A clinical laboratory scientist licensed pursuant to chapter 3 of the 
Business and Professions Code. 

(b) In order to be eligible for licensure as a clinical histocompatibility 
scientist an applicant shall have been certified as a Clinical Histocompa- 
tibility Technologist by the American Board of Histocompatibility and 
Immunogenetics, either: 

(1) Prior to January 1, 1997 and have had at least 6 years' experience 
in all areas of clinical histocompatibility testing in a clinical laboratory, 
or 

(2) After January 1 , 1 997 and have a baccalaureate degree in biologi- 
cal or clinical science and one year of clinical laboratory experience in 
all areas of clinical histocompatibility testing in a clinical laboratory. 
NotE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1209. 1 , 
1210 and 1261, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-19-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section, transmitted to OAL 2-2 1-2001 and filed 4-3-2001 (Register 2001, No. 
14). 

§ 1 031 .2. Licensure of Clinical Cytogeneticist Scientists. 

(a) Each person performing high complexity tests or examinations in 
the specialty of cytogenetics in a licensed clinical laboratory shall pos- 
sess a valid clinical cytogeneticist scientist license except for the follow- 
ing persons: 

( 1 ) A physician and surgeon licensed by the State to practice medicine 
pursuant to chapter 5 of division 2 of the Business and Professions Code; 
or 

(2) A clinical cytogeneticist licensed to direct a cytogenetics laborato- 
ry pursuant to chapter 3; or 



Page 20.2 



Register 2003, No. 34; 8-22-2003 



Title 17 



State Department of Health Services 



§ 1031.4 



• 



• 



(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3; or 

(4) A clinical laboratory scientist licensed pursuant to chapter 3. 

(b) In order to be eligible for licensure as a clinical cytogeneticist sci- 
entist, an applicant shall: 

( 1 ) Hold a baccalaureate or an equivalent or higher degree, which shall 
include at least 25 semester or 38 quarter hours in biology, chemistry or 
clinical laboratory science from an accredited college or university, and 

(2) Provide evidence of satisfactory performance on a written ex- 
amination in the specialty of cytogenetics administered by the National 
Credentialing Agency for Laboratory Personnel (NCA), and either: 

(A) On or after March 14, 2003, have completed at least one year train- 
ing and/or experience in clinical cytogenetics in a clinical laboratory cer- 
tified by the Centers for Medicare and Medicaid Services (CMS) in clini- 
cal cytogenetics. This training shall be approved by the department 
pursuant to Section 1035 and acceptable for admission to an examination 
by the NCA in the specialty of cytogenetics; or 

(B) Prior to March 14, 2003, have completed training and/or experi- 
ence in clinical cytogenetics, which is acceptable for admission to an ex- 
amination by the NCA in the specialty of cytogenetics, in a clinical labo- 
ratory certified by CMS in clinical cytogenetics or in histopathology 
(cytogenetics). 

NoTE; Authority cited: Sections 1224, 1261 and 1261. 5, Business and Professions 
Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 
1205, 1206. 1206.5, 1210, 1222.5, 1261, 1261.5, 1262, 1282 and 1286, Business 
and Professions Code. 

History 

1 . New section filed 3-13-2003 as an emergency; operative 3-13-2003 (Register 
2003, No. 11 ). A Certificate of Compliance must be transmitted to OAL by 
7-1 1 -2003 or emergency language will be repealed by operation of law on the 
following day. 

2. Certificate of Compliance as to 3-13-2003 order transmitted to OAL 
7-10-2003 and filed 8-21-2003 (Register 2003, No. 34). 

§ 1 031 .3. Licensure of Clinical Genetic Molecular Biologist 
Scientists. 

(a) Each person performing high complexity tests or examinations in 
the subspecialty of genetic molecular biology in a licensed clinical labo- 
ratory shall possess a valid clinical genetic molecular biologist license 
except for the following persons: 

( 1 ) A physician and surgeon licensed by the State to practice medicine 
pursuant to chapter 5 of division 2 of the Business and Professions Code; 
or 



(2) A clinical genetic molecular biologist licensed to direct a genetics 
laboratory pursuant to chapter 3; or 

(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3; or 

(4) A clinical laboratory scientist licensed pursuant to chapter 3. 

(b) In order to be eligible for licensure as a clinical genetic molecular 
biologist scientist, an applicant shall hold a baccalaureate or an equiva- 
lent or higher degree in a biological or clinical laboratory science, or field 
related to genetics from an accredited college or university; and 

( 1 ) Have completed at least one year training and/or experience in clin- 
ical genetic molecular biology in a clinical laboratory certified by the 
Center for Medicare & Medicaid Services (CMS), performing high com- 
plexity testing in clinical genetic molecular biology. This training and/or 
experience shall be acceptable for admission to an examination by the 
National Credentialing Agency for Laboratory Personnel (NCA) in the 
specialty of molecular biology. On or after March 14, 2003, this training 
shall be approved by the department pursuant to Section 1035; and 

(2) Provide evidence of satisfactory performance on a written ex- 
amination in molecular biology administered by the NCA. 

NOTE; Authority cited: Sections 1224, 1261 and 1261.5, Business and Professions 
Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 
1205, 1206, 1206.5, 1210, 1222.5, 1261, 1261.5, 1262, 1282 and 1286, Bu.siness 
and Professions Code. 

History 

1. New section filed 3-1 3-2003 as an emergency; operative 3-13-2003 (Register 
2003, No. 11). A Certificate of Compliance must be transmitted to OAL by 
7-1 1-2003 or emergency language will be repealed by operation of law on the 
following day. 

2. Certificate of Compliance as to 3-13-2003 order transmitted to OAL 
7-10-2003 and filed 8-21-2003 (Register 2003, No. 34). 



§ 1 031 .4. Requirements and Timeframes for Applications 
for Licensure and Certification. 

(a) Applications for admission to a state-administered Hcensing ex- 
amination shall be complete when the information specified in Section 
103 1 .4(b) has been received by the department. For an applicant to be eli- 
gible for a scheduled examination, the completed application must be 
postmarked at least 120 days prior to the examination date as published 
by the Department of Health Services. When applying for admission to 
the examination, the applicant shall state whether he or she has previous- 
ly applied to the department for admission to an examination. 



[The next page is 20.3. 



Page 20.2(a) 



Register 2003, No. 34; 8-22-2003 



Title 17 



State Department of Health Services 



§ 1031.4 



(b) An application for licensure to direct a clinical laboratory or to per- 
form clinical laboratory tests or examinations under Chapter 3 shall be 
considered complete when the following is provided to the department: 

( 1 ) Name and address of the applicant, including city, state and zip 
code; and 

(2) Social security number of the applicant (Pursuant to the authority 
found in Section 1224 of the Business and Professions Code and in Sec- 
tion 100275 of the Health and Safety Code, and as required by Section 
17520 of the Family Code, it is mandatory to provide the social security 
number. The social security number will be used for purposes of identifi- 
cation.); and 

(3) Gender and birthdate; and 

(4) License for which the applicant is applying; and 

(5) Whether the applicant has or has not been convicted of any felonies 
or misdemeanors other than minor traffic violations; and 

(6) Documentation of the applicant's education including: 

(A) Name, address, major course of study, dates of attendance, num- 
ber of credits, and degree/completion date for all colleges and universi- 
ties attended by the applicant; and 

(B) Official transcripts from the registrar of all accredited colleges or 
universities attended by the applicant showing all courses, course credits, 
degrees conferred and date of conference; and 

(C) Official transcripts from non-United States colleges or universi- 
ties which are not in English shall be returned to the applicant to obtain 
translation from a translation service approved in the United States for 
legal or government documents. 

(7) Documentation of the applicant's training including: 

(A) Name and address of training program, dates of training, specialty 
and subspecialty areas of training, length of time in each specialty and 
subspecialty area of training; and 

(B) Signed documentation from the training program director that this 
training has been successfully completed; and 

(8) Documentation of the applicant's experience, appropriate to the 
specific license for which the applicant is applying, including the follow- 
ing: 

(A) Facility name, address, dates of employment, number of hours per 
week employed, the specialties and subspecialties in which clinical labo- 
ratory tests or examinations were performed and a description of clinical 
laboratory tests or examinations performed; and 

(B) Signed documentation of such experience from the director of the 
laboratory; and 

(9) Evidence of satisfactory performance on a licensing examination 
pursuant to Section 1029.81; and 

(10) Signature of the applicant, telephone number and date of appUca- 
tion; and 

(11) Payment of license application fee pursuant to Business and Pro- 
fessions Code Section 1300. 

(c) An application for certification in phlebotomy shall be considered 
complete when the following is provided to the department: 

(1) Name and address of the applicant, including city, state and zip 
code; and 

(2) Social security number of the applicant (Pursuant to the authority 
found in Section 1224 of the Business and Professions Code and in Sec- 
tion 100275 of the Health and Safety Code, and as required by Section 
17520 of the Family Code, it is mandatory to provide the social security 
number. The social security number will be used for purposes of identifi- 
cation.); and 

(3) Gender and birthdate; and 

(4) Category of phlebotomy certification for which the applicant is ap- 
plying; and 

(5) Whether the applicant has or has not been convicted of any felonies 
or misdemeanors other than minor traffic violations; and 

(6) Documentation of the applicant's education including; 

(A) Name, address, dates of attendance, coursework completed and 
graduation as verified by official school transcripts; or 



(B) Documentation of a passing score on the general educational de- 
velopment (GEO) test or equivalent education as evaluated by the Amer- 
ican Association of Collegiate Registrars and Admissions Officers for 
secondary education; or 

(C) For official school transcripts which are not in English, documen- 
tation of equivalent education as obtained through translation into Eng- 
lish from a translation service approved in the United States for legal or 
government documents; and 

(7) Certification of the applicant's instruction in phlebotomy as speci- 
fied in Section 1035.1(h); and 

(8) Cerfification of the applicant's on-the-job experience in phleboto- 
my, if applicable, including: 

(A) Name and address of laboratory where employed, dates of em- 
ployment, number of hours of experience in techniques specified in Sec- 
tion 1035. 1(f) and an estimate of the number of skin punctures, venipunc- 
tures or arterial punctures performed pursuant to the Business and 
Professions Code Secfion 1 220(d)( 1 ) or (d)(2)(A) that fulfills all the sam- 
pling requirements of all clinical laboratory tests or examinafions; and 

(B) Signed documentation from the director of the laboratory that the 
above informafion accurately represents the applicant's experience in 
phlebotomy; and 

(9) Evidence of satisfactory performance on a certification examina- 
tion in phlebotomy administered by a certifying organization that was ap- 
proved by the department pursuant to Section 103 1.7 at the time the ex- 
amination was administered; and 

(10) Signature of the applicant, telephone number and date of applica- 
tion; and 

(11) Payment of a two-year certification fee of $50. 

(d) Timeframes for processing applications for licensure to direct a 
clinical laboratory or to perform clinical laboratory tests or examinations 
or for certification to perform phlebotomy pursuant to Chapter 3 shall be 
as follows: 

( 1 ) The department shall notify the applicant in writing, within 90 days 
of receipt of an application, of one of the following: 

(A) The application is complete and will be processed by the depart- 
ment; or 

(B) The application is incomplete and not accepted for processing. The 
department's written notification shall include the specific information, 
documentation or fee in which the application is deficient; or 

(C) The application has been reviewed and does not meet the require- 
ments and that approval is denied. The department shall give written noti- 
fication of the basis for the denial. 

(2) The department shall notify the applicant within 90 days of post- 
mark date of resubmission of application requirements pursuant to Sec- 
tion 1031.4(d)(1)(B) whether the application has been approved or de- 
nied. 

(3) Written notification by the department to applicants shall be 
deemed to occur on the date of the postmark from the department. 

(4) The department shall deem an application abandoned by an appli- 
cant who fails to respond or to supply all information, documents, verifi- 
cations or payment of applicable fees within 30 days of notification by 
the department. 

(5) The department's time periods for processing an application for li- 
censure or certification from the date the application is complete to the 
date the final decision is made regarding an approval are as follows: 

(A) The median time for processing an application is 90 days; 

(B) The minimum time for processing an application is 30 days; and 

(C) The maximum time for processing an application is 1 50 days. 

(e) Certification shall be valid for a period of 2 years unless revoked. 
(0 Failure to meet the requirements of this section shall be good cause 

for denial or revocation of approval by the department. 

(g) All applicants, licensees and certificants pursuant to Section 
1031.4 shall notify the department in writing of any change(s) of name 
and /or address within 30 days after the change(s) has occurred. 



Page 20.3 



Register 2003, No. 2; 1 - 1 - 2003 



§ 1031.5 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; and Section 17520. Family Code. Reference: 
Sections 1203, 1204, 1205, 1207, 1209. 1209,1, 1210, 1220, 1241. 1242, 1242.5, 
1246, 1260, 1261, 1261.5, 1263, 1264, 1282, 1300, 1301, 1301.1 and 1320, Busi- 
ness and Professions Code; Section 120580, Health and Safety Code; and Section 
15376, Government Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 

2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000. No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-1 9-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-2 1-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section and Note, transmitted to OAL 2-2 1- 2001 and filed 4-3-2001 (Register 

2001, No. 14). 

5. Amendment of section heading, section and Note filed 1-9-2003; operative 
4-9-2003 (Register 2003, No. 2). 

§ 1031.5. Requirements and Timeframes for Renewal of 
Licenses and Certificates. 

(a) In order to maintain a license in active status, licenses shall be re- 
newed by filing a renewal application within 60 days prior to the end of 
the license period. 

(b) A complete license renewal application shall include name and ad- 
dress of the licensee, license number, current work location(s), documen- 
tation of continuing education credits, an attestation stating whether the 
licensee has or has not been convicted of any felonies or misdemeanors 
other than minor traffic violations in the previous two years, license re- 
newal fee, signature and date of application for renewal. 

(c) In order to maintain a phlebotomy certificate in active status, certif- 
icates once approved shall be renewed at biennial intervals by filing a re- 
newal application within 60 days prior to the end of the certificate period. 

(d) A complete phlebotomy certificate renewal application shall in- 
clude name and address of the certificant, certificate number, current 
work location(s), documentation of continuing education performed dur- 
ing the previous 24 months, an attestation stating whether the certificant 
has or has not been convicted of any felonies or misdemeanors other than 
minor traffic violations in the previous two years, certification renewal 
fee of $50, signature and date of application for renewal. 

NOTE; Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1203, 1204, 1205, 1207, 
1209, 1209.1, 1210. 1226, 1241, 1242, 1242.5, 1246, 1260, 1261, 1261.5, 1263, 
1264, 1282, 1300, 1301 and 1301.1, Business and Professions Code; and Section 
120580, Health and Safety Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New secUon refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 1 0-19-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 
14). 

5. Amendment of section heading, section and Note filed 1-9-2003; operative 
4-9-2003 (Register 2003, No. 2). 

§ 1031.7. Conditions for Approval of Certifying 

Organizations to Administer Phlebotomy 
Certification Examinations. 

(a) In order for a certifying organization to be eligible for approval by 
the department to administer a phlebotomy certification examination for 



state certification purposes, the certifying organization shall meet the fol- 
lowing conditions: 

( 1 ) The certifying organization shall be a national, independent, not- 
for-profit, professional certifying organization; and 

(2) The certifying organization shall offer examinations in phleboto- 
my; and 

(3) The certifying organization shall provide the following to the de- 
partment: 

(A) The organization's name and address; and 

(B) Names of the organization's officers and board of directors; and 

(C) A description of the organization's structure; and 

(D) The identity of the person designated by the organization to be re- 
sponsible for overseeing the administration and coordination of all ex- 
amination activities; and 

(E) A schedule of dates and times that the examination will be con- 
ducted within the state; and 

(F) Listing of procedures for monitoring the content, quality, validity 
and relevance of the phlebotomy examinations pursuant to Section 
1031.7(b); and 

(G) The philosophy of the organization, demonstrating a commitment 
to accurate assessment of a candidate's preparation for phlebotomy certi- 
fication. 

(b) In order for a certifying organization's examination to be approved 
for certification purposes, the organization shall document the following 
standards to support a request for approval: 

(1) Evaluation of relevant standards in phlebotomy and how the orga- 
nization's examinations address knowledge and skills that would assure 
competence of the candidate; and 

(2) Explanation of how the examinations are developed by the orga- 
nization and the qualifications of person(s) who develop the examination 
questions; and 

(3) Documentation that the organization's examinations are subject to 
annual review for current relevance; and 

(4) Demonstration of the ability of the organization to evaluate its ex- 
aminations, subjecting the examinations to validity and reliability assess- 
ments using psychometric performance standards, and the capability of 
the organization to provide this information at least once yearly or upon 
request to the department. 

(c) An organization approved to administer a phlebotomy examination 
shall: 

(1) Agree to make the content of its examinations available to the de- 
partment for confidential review; and 

(2) Demonstrate how it will maintain security during administration 
of the examination, ensure the identity of the examinee, and maintain the 
confidentiality of the examination; and 

(3) Document how it will make its records accessible to the department 
regarding those persons participating in the examination and their scores; 
and 

(4) Provide verification of those persons successfully passing the cer- 
tification examination to the department and shall maintain these records 
for five years; and 

(5) Issue a certificate to those passing the examination with the exam- 
inee's name, name of the cerufying organization, type of certificate, ef- 
fective date and official signature. 

(d) Timeframes for processing apphcations for approval of a certify- 
ing organization's certification examinafion shall be as follows: 

(1) Within 90 calendar days of receipt of an application, the depart- 
ment shall inform the organization in writing that the application is either 
complete and accepted for review or that it is deficient and what specific 
information or documentation is required to complete the application. 

(2) Within 180 calendar days from the date of filing a completed ap- 
plication, the department shall inform the applicant certifying organiza- 
tion in writing whether the organization has been approved or denied as 
a certifying organization for the administration of the certification ex- 
amination. 



Page 20.4 



Register 2003, No. 2; 1-10-2003 



Title 17 



State Department of Health Services 



§ 1031.8 



• 



• 



(3) The department shall deem an application abandoned by an appli- 
cant certifying organization that fails to respond or to supply all informa- 
tion, documents, or verifications within 30 days of notification pursuant 
to Section 1031.7(d)(1). 

(4) The department' s time periods for processing an application for ap- 
proval as a certifying organization, from the receipt of the initial applica- 
tion to the final decision regarding the approval, are as follows: 

(A) The median time for processing is 180 calendar days. 

(B) The minimum time for processing is 90 calendar days. 

(C) The maximum time for processing is 360 calendar days. 

(e) Approval shall be valid for a period of four years unless revoked. 

(0 To apply for renewal, a certifying organization shall file a renewal 
application at least 120 days prior to the end of the approval period pro- 
viding the following: 

( 1 ) The name and address of the certifying organization; and 

(2) Names of the organization's officers and board of directors; and 

(3) Name of the person designated by the organization to be responsi- 
ble for overseeing the administration and coordination of all examination 
activities; and 

(4) A schedule of dates and times that the examination will be con- 
ducted within the state for the next 12 months; and 

(5) A copy of the current examination; and 

(6) Signature of the program director and date of application for re- 
newal. 

(g) Failure to meet the requirements of this section shall be good cause 
for denial or revocation of approval by the department. 

(h) A certifying organization shall notify the department in writing of 
any change(s) in the information and material required by Subsections 
(a) through (c) within 30 days after the change(s) has occurred. 
NOTH: Authority cited: Sections 1224 and 1320, Business and Professions Code; 
and Section 100275. Health and Safety Code. Reference: Sections 1242, 1242.5, 
1246 and 1269, Business and Professions Code; and Section 120580, Health and 
Safety Code. 

History 

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2). 

§ 1 031 .8. Conditions for Approval of a Certifying 
Organization to Administer a Certifying 
Examination for Licensure Purposes. 

(a) In order for a certifying organization to be eligible for approval by 
the department to administer a category of certifying examination, the or- 
ganization shall file a complete application that consists of the following: 

( 1 ) Documentation that the certifying organization is a national, inde- 
pendent, not-for-profit, professional certifying organization; and 

(2) The organization's name and address; and 

(3) Names of the organization's officer(s) and board of directors; and 

(4) Description of the organization's structure and organizational 
chart; and 

(5) The identity of the person designated by the organizadon to be re- 
sponsible for overseeing the administration and coordination of ex- 
amination activities; and 

(6) A mission statement that demonstrates the philosophy of the certi- 
fying organization commits to an accurate assessment of a candidate's 
preparation in the clinical laboratory science category in which the candi- 
date is examined; and 

(7) Schedule of dates that the examination will be available to Califor- 
nia licensure applicants during the next four years; and 

(8) Listing of procedures for monitoring the content, quality, validity, 
reliability and relevance of the examination in the specialty being tested, 
and 

(9) Demonstration of how the organization's examination addresses 
the relevant standards in the clinical laboratory science category being 
examined, and how it evaluates the knowledge and skills that would as- 
sure competence of the candidate; and 

( J 0) Exp]anaUon of how the examination structure is developed by the 
organization, and the qualifications of person(s) who develop the ex- 
amination questions; and 



(11) Documentation that the organization's examination is subject to 
annual review for current relevance; and 

(12) Demonstration of the ability of the organization to evaluate its ex- 
amination, subjecting it to validity and reliability assessments using psy- 
chometric performance standards, and the capability of the organization 
to provide this information at least annually or upon request to the depart- 
ment; and 

(13) Explanation of how the examination is developed and weighted 
using a job task survey to determine knowledge and skills required to be 
competent in the examination category; and 

(14) Explanation of how examination questions are established, eva- 
luated and updated to match current practice for the category; and 

(15) Explanation of how the cutoff score for those successfully passing 
the examination is determined; and 

(16) Documentation of performance statistics for the examination dur- 
ing the previous five years, including pass/fail rate, number of applicants 
and number accepted to the examination for each time that the examina- 
tion has been administered by the certifying organization during the five 
years immediately prior to the date of application, or, for specialties that 
have been established for less than five years, during the period dating 
from the establishment of the specialty to the date of the application; and 

( 1 7) Submission of printed copies of examinations given each year for 
the previous four years, if the examinations were offered. These ex- 
amination shall be subject to confidential review by the department, shall 
not be copied, and shall be returned to the organization; and 

( 1 8) Submission of an agreement to provide the examination to candi- 
dates who have been approved for admission to the examination by the 
department; and 

(19) Submission of an agreement to provide verification of those per- 
sons successfully passing the examination to the department and to main- 
tain these records for five years; and 

(20) Submission of an agreement to give evidence of satisfactory per- 
formance as official notification to those passing the examination with 
the examinee's name, name of the certifying organization, examination 
category, effecUve date and official signature; and 

(21) Demonstration how the organization will maintain security dur- 
ing development and administration of the examination, ensure the iden- 
dty of the examinee, and maintain the confidentiality of the examination; 
and 

(22) Listing of procedures in use and required of the organization's 
personnel to ensure security and confidentiality of the examination, and 
steps to be taken if a breach is discovered; and 

(23) An agreement that a breach of security shall be reported to the de- 
partment and that the department is authorized to investigate and with- 
draw approval of the examination category; and 

(24) Documentation how the organization will make its records acces- 
sible to the department regarding those persons participating in the ex- 
amination and their scores; and 

(25) The name, tide, and signature of the person who is responsible for 
overseeing the administration and coordination of all examinadon activi- 
ties, and the date the application was signed. 

(b) Initial approval of an organization's examination category shall in- 
clude confidential review of an examination given each year up to four 
years immediately preceding the date of approval, so that examinations 
taken during this time shall be acceptable for licensure purposes. 

(c) Timeframes for processing applications for approval of a certifying 
organization's examination in a clinical laboratory science category for 
licensure purposes shall be as follows; 

(1) The department shall nodfy the applicant organization within 90 
days of submission of an application of one of the following: 

(A) That the application is complete and acceptable for processing by 
the department; or 

(B) That the application is incomplete and not accepted for processing. 
This notification shall include the specific information or documentation 
that the applicant shall submit within 30 days in order for the department 
to consider the application acceptable; or 



Page 20.5 



Register 2005, No. 37; 9-16-2005 



§ 1031.9 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(C) That the appHcation has been reviewed and does not meet the re- 
quirements of this section and that approval is denied. 

(2) The department shall consider an application to have been aban- 
doned by any applicant who fails to respond to the department's request 
to submit specific information or documentation within 30 days of notifi- 
cation pursuant to Section 1031.8(c)(1)(B). 

(d) Written notification by the department to the applicant organiza- 
tion shall be considered to occur on the date the documents are post- 
marked. 

(e) A certifying organization shall notify the department in writing of 
any change in the information and materials required by this section with- 
in 30 days after the change has occurred. 

(f) Failure to meet and maintain the requirements of this section shall 
be good cause for denial or revocation of approval by the department. 
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275. Health and Safety Code. Reference: Sections 1208, 1228, 1261, 1261.5, 
1262, 1263 and 1264, Business and Professions Code. 

History 

1. New section filed 1-13-2005 as an emergency; operative 1-1 3-2005 (Register 
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by 
5-13-2005 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Regis- 
ter 2005, No. 19). A Certificate of Compliance must be transmitted to OAL by 
9-12-2005 or emergency language will be repealed by operation of law on the 
following day. 

3. Certificate of Compliance as to 5-12-2005 order, including amendment of sub- 
sections (a)(12), (a)(17), (a)(20). (a)(25) and (b) and repealer of subsection (c) 
with subsection relettering, transmitted to OAL 8-3-2005 and filed 9-12-2005 
(Register 2005, No. 37). 

§ 1 031 .9. Conditions for Renewal of a Certifying 

Organization's Approval to Administer 
Examinations Acceptable for Licensure 
Purposes. 

(a) Approval of a certifying organization shall be valid for a period of 
four years unless revoked. At least 120 days prior to the end of the ap- 
proval period, the certifying organization that wants to continue approval 
of its examination shall apply for reapproval. Failure to reapply 120 days 
in advance shall cause a lapse in approval after which time the examina- 
tion would not be acceptable for licensure purposes until the certifying 
organization regains approval. A certifying organization that fails to 
reapply at least 1 20 days in advance and subsequently elects to seek ap- 
proval shall make application pursuant to Section 1031.8. 

(b) To apply for renewal of a certifying organization' s approval to ad- 
minister examinations, the organization shall provide the following: 

(1) The name and address of the certifying organization; and 

(2) Names of the organization's officer(s) and board of directors; and 

(3) Name of the person designated by the organization to be responsi- 
ble for overseeing the administration and coordination of all examination 
activities; and 

(4) A schedule of dates that the examination will be available to 
California applicants during the next four years; and 

(5) A summary of the performance statistics of the examination during 
the previous approval period, including the number of California appli- 
cants applying for, and successfully passing, the certifying examination, 
the applicant scores, what efforts have been made to evaluate the ex- 
amination and update the examination questions to match cun-ent prac- 
tice for the category; and 

(6) The name, title and signature of the person responsible for oversee- 
ing the administration and coordination of all examination activities and 
date of application for renewal. 

(c) The timeframes for processing an application of a certifying orga- 
nization seeking renewal of its examination approval shall be as follows: 

(1 ) The certifying organization shall submit an application for renewal 
of approval of its examination at least 120 days prior to the end of the ap- 
proval period. 

(2) Within 30 days of receipt of a renewal application, the department 
shall inform the organization in writing that the renewal application is 



complete and accepted for review, or deficient and what specific in- 
formation or documentation is required to complete the application. 

(3) Within 30 days of receiving a completed renewal application, the 
department shall inform the applicant organization in writing whether the 
examination has been reapproved or denied. 

(d) Failure to meet and maintain the requirements of this .section shall 
be good cause for denial of reapproval by the department. 
NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1208, 1228, 1261, 1261.5, 
1262, 1263 and 1264, Business and Professions Code. 

History 

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register 
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by 
5-13-2005 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Regis- 
ter 2005, No. 19). A Certificate of Compliance must be transmitted to OAL by 
9-12-2005 or emergency language will be repealed by operation of law on the 
following day. 

3. Certificate of Compliance as to 5-12-2005 order, including amendment of sub- 
sections (a), (b)(6) and (c)(2), transmitted to OAL 8-3-2005 and filed 
9-12-2005 (Register 2005, No. 37). 



§ 1032. Examination for Clinical Laboratory Technologist's 
License. 

With the exception as provided in Section 1 262 of the Business and 
Professions Code, written, oral, or practical examinations shall be con- 
ducted by the department to aid it in judging the qualifications of appli- 
cants for licensure as clinical laboratory technologists. In addition to the 
requirements for licensure as specified in Section 1261 of the Business 
and Professions Code, the prerequisites for entrance into the licensing ex- 
amination shall be one of the following: 

(a) Graduation from a college or university maintaining standards 
equivalent, as determined by the department, to those institutions accred- 
ited by the Western Association of Schools and Colleges, or an essential- 
ly equivalent accrediting agency, with a baccalaureate and a major in 
clinical laboratory science, the last year of which course shall have been 
primarily clinical laboratory procedures in a clinical laboratory training 
school acceptable to the department; or 

(b) Graduation from a college or university maintaining standards 
equivalent, as determined by the department, to those institutions accred- 
ited by the Eastern Association of Schools and Colleges, or an essentially 
equivalent accrediting agency, with a baccalaureate and courses perti- 
nent to the clinical laboratory field as may be determined by the depart- 
ment plus one year as a clinical laboratory technologist trainee or the 
equivalent as determined by the department in a clinical laboratory ac- 
ceptable to the department; provided, however, that a baccalaureate ob- 
tained after July 1, 1973, must include at least: 

(1)16 semester or equivalent quarter hours of chemistry, including in- 
struction in analytical and biological chemistry; 

(2) 18 semester or equivalent quarter hours of biological science, in- 
cluding instruction in immunology, hematology and medical microbiol- 
ogy which may include bacteriology, mycology, virology and parasitolo- 
gy; 

(3) 3 semester or equivalent quarter hours of physics, including in- 
struction in principles of light and electricity; or 

(c) A minimum of two years of experience as a licensed trainee or the 
equivalent as determined by the department doing clinical laboratory 
work embracing the various fields of clinical laboratory activity in a clin- 
ical laboratory acceptable to the department and 90 semester hours or 
equivalent quarter hours of university or college work in which are in- 
cluded the following coursed, or essential equivalent as may be deter- 
mined by the department: general inorganic chemistry — 8; quantitative 
analysis — 3; basic biological sciences — 8; bacteriology — 4; provided, 
however, that university or college work completed after July 1, 1973, 
must include at least: 

(1)16 semester or equivalent quarter hours of chemistry, including in- 
struction in analytical and biological chemistry; 



Page 20.6 



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Title 17 



State Department of Health Services 



8 1033 



(2) 18 semester or equivalent quarter hours of biological science in- 
cluding instruction in immunology, hematology and medical microbiol- 
ogy which may include bacteriology, mycology, virology and parasitolo- 
gy; 

(3) 3 semester or equivalent quarter yours of physics, including in- 
struction in principles of light and electricity. 

NOTK: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: 
Sections 1246, 1261, 1262, 1263, 2164 and 1301. Business and Professions Code. 

History 

1 . New section filed 1 1-25-70 as procedural and oraanizational; designated effec- 
tive 1 1-24-70 (Register 70, No. 48). 

2. Certificate of Compliance— Sec. 11422.1, Gov. code, filed 1-20-71 (Register 
71. No. 4). 

3. Amendment filed 6-8-72; effective thirtieth day thereafter (Register 72. No. 
24). 

§ 1 032.5. Licensure of Medical Laboratory Technicians. 

(a) In order to qualify for licensure as a medical laboratory technician, 
a person shall apply for a license pursuant to Section 1 03 1 .4 (b) and meet 
the following requirements: 

( 1 ) Have successfully completed at least 60 semester (90 quarter) units 
from an accredited college or university. The coursework shall consist of 
at least 36 semester units of physical and biological sciences with an em- 
phasis on applied clinical science. Coursework shall include 6 semester 
units of chemistry and 6 semester units of biology appropriate for transfer 
to a baccalaureate program in science, taken prior to, or concurrendy 
with, training or experience; and 

(2) Have met the following training or experience requirements by 
documenting one of the following: 

(A) Graduating from a medical laboratory technician training program 
accredited by the National Accrediting Agency for Clinical Laboratory 
Sciences (NAACLS); or 

(B) Graduating from a medical laboratory technician training program 
approved by the department pursuant to Section 1035.3; or 

(C) Meeting admission requirements for a clinical laboratory scientist 
licensing examination, as determined by the department pursuant to Sec- 
tion 1032; or 

(D) Completing a minimum of three years on-the-job practical expe- 
rience within the previous five years, in a clinical laboratory outside 
California as a medical laboratory technician, with evidence of satisfac- 
tory performance on an examination given by a certifying organization 
for medical laboratory technicians, performing tests in the specialties of 
chemistry, hematology, microbiology, and immunology. This work ex- 
perience shall include at least 480 hours in each of these specialties and 
shall be documented by the laboratory director(s) of the laboratory(ies) 
employing the applicant pursuant to Secdon 1031.4(b)(8); or 

(E) Completing a minimum of three years on-the-job practical experi- 
ence within the previous five years, in a clinical laboratory outside 
California as a clinical laboratory scientist, with evidence of sadsfactory 
performance on an examination given by a certifying organizadon for 
clinical laboratory scientists, performing tests in the specialties of chem- 
istry, hematology, microbiology, and immunology. This clinical labora- 
tory scientist, also called medical technologist in some states, need not 
be California licensed pursuant to Business and Professions Code section 
1204, but shall have work experience outside California of at least 480 
hours in each of these specialties as documented by the laboratory direc- 
tor(s) of the laboratory(ies) employing the applicant pursuant to Section 
1031.4(b)(8); or 

(F) Completing a minimum of three years on-the-job pracdcal experi- 
ence within the previous five years, as a medical laboratory technician 
or clinical laboratory sciendst in a California physician office laboratory 
or in a laboratory owned and operated by the United States of America. 
This person shall have evidence of satisfactory performance on an ex- 
amination given by a cerdfying organizadon for medical laboratory tech- 
nicians or clinical laboratory scientists, respecdvely, and have performed 
tests in the specialties of chemistry, hematology, microbiology and im- 
munology. This work experience shall include at least 480 hours in each 
of these specialdes, and shall be documented by the physician(s) direct- 



ing the laboratory(ies) employing the applicant pursuant to Section 
1031.4(b)(8); and 

(3) Have passed a written examination for medical laboratory techni- 
cians administered by a certifying organization for medical laboratory 
technicians approved by the department pursuant to Section 1 03 1 .8. The 
department shall, for licensure purposes, accept evidence of satisfactory 
performance on examinations taken within the four years previous to de- 
partment approval of a certifying organizadon's medical laboratory tech- 
nician examination. The applicant shall have also passed a separate writ- 
ten, self-administered examinadon on California clinical laboratory law 
provided by the department. This self-administered test shall accompany 
the applicafion. A minimum passage rate of 70 percent shall be required. 

(b) A licensed medical laboratory technician shall be authorized to: 

( 1 ) Perform tests and examinations classified as waived and moderate 
complexity by Centers for Disease Control and Prevention in the special- 
des of chemistry, including roudne chemistry, urinalysis, endocrinology 
and toxicology; hematology including coagulation; microbiology, in- 
cluding bacteriology, mycobacteriology. mycology, parasitology and 
virology; and immunology, including syphilis serology and general im- 
munology, with the excepUon of those moderate complexity tests requir- 
ing microscopy, or in the specialty of immunohematology. 

(2) Perform phlebotomy, but shall not perform skin tests for specific 
diseases pursuant to Secdon 1242 of the Business and Professions Code. 

(3) Perform tests and examinations under the supervision of a licensed 
physician and surgeon, or a doctoral scientist, clinical laboratory bioana- 
lyst, clinical laboratory scienUst, or clinical laboratory specialist licensed 
under Chapter 3. On-site supervision shall be required during the entire 
dme the medical laboratory technician performs moderate complexity 
clinical laboratory tests or examinadons. The ratio of medical laboratory 
technician to supervisor at the site of moderate complexity testing shall 
not exceed four to one. 

(4) Report test results and perform phlebotomy only after competency 
has been documented by the laboratory director pursuant to Section 
1209(e) of the Business and Professions Code. 

(5) Supervise Limited Phlebotomy Technicians or Cerdfied Phleboto- 
my Technician Is. 

(c) The license applicafion fee and license renewal fee for a medical 
laboratory technician shall be the same as the license applicadon fee and 
hcense renewal fee for a clinical laboratory scientist pursuant to Section 
1300(c) and (e) of the Business and Professions Code. 

(d) A medical laboratory technician shall complete twelve hours of 
continuing educadon each year as a condition for renewal. 

Note: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1202.5, 1204, 1206, 1206.5, 
1208, 1209, 1210, 1242, 1260.3, 1261, 1275, 1300 and 1 320, Business and Profes- 
sions Code. 

History 

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register 
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by 
5-13-2005 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 5-12-2005 as an emergency; operative .5-14-2005 (Regis- 
ter 2005, No. 19). A Certificate of Compliance must be transmitted to OAL by 
9-12-2005 or emergency language will be repealed by operation of law on the 
following day. 

3. Certificate of Compliance as to 5-12-2005 order, including amendment of sub- 
secdons (a)(3), (b)( 1 ), (b)(3) and (b)(5), transmitted to OAL 8-3-2005 and filed 
9-12-2005 (Register 2005, No. 37). 

§1033. Trainee Requirements. 

In addifion to the requirements for licensure as specified in Section 
1263 of the Business and Professions Code, the prerequisites for licen- 
sure as a trainee shall be as follows: 

(a) Clinical Laboratory Technologist Trainee. Applicants shall ha\ e 
graduated from a college or university maintaining standards equiv alent, 
as determined by the department, to those insdtufions accredited by the 
Western Associafion of Schools and Colleges or an essentially equiva- 
lent agency with a baccalaureate and a major in clinical laboratory sci- 
ence, or a baccalaureate and courses pertinent to the clinical laboratory 
field as may be determined by the department. An individual who is not 



Page 20.7 



Register 2005, No. 37; 9-16-2005 



§1034 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



a graduate but possesses at least 90 semester hours or equivalent quarter 
hours of university or college work may be licensed as a clinical laborato- 
ry technologist trainee, provided he will be granted a baccalaureate at the 
conclusion of 1 2 months of training, and have completed at least 90 se- 
mester hours or equivalent quarter hours, must have included in the col- 
lege work the following courses or essential equivalent as may be deter- 
mined by the department: general inorganic chemistry — 8; quantitative 
analysis — 3; basic biological sciences — 8; bacteriology— 4; provided, 
however, that university or college work completed after July 1, 1973, 
must include at least: 

(1)16 semester or equivalent quarter hours of chemistry, including in- 
struction in analytical and biological chemistry; 

(2) 1 8 semester or equivalent quarter hours of biological science, in- 
cluding instruction in immunology, hematology and medical microbiol- 
ogy which may include bacteriology, mycology, virology and parasitolo- 
gy; 

(3) 3 semester or equivalent quarter hours of physics including instruc- 
tion in principles of light and electricity. 

(b) Limited Technologist Trainee. Aj^plicants shall have graduated 
from a college or university maintaining standards equivalent, as deter- 
mined by the department, to those institutions accredited by the Western 
Association of Schools and Colleges or an essentially equivalent accred- 
iting agency with a baccalaureate and a major in the specialty for which 
licensure is sought. If the major is not designated by the college or univer- 
sity as one of those required under this chapter for limited technologist 
licenses in clinical chemistry, clinical microbiology, immunohematolo- 
gy, or toxicology, the department may determine the essentially equiva- 
lent major. 

NOTE: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: 
sections 1246, 1261, 1262, 1263, 1264 and 1301, Business and Professions Code. 

History 

1 . New section filed 1 1-25-70 as procedural and organizational; designated effec- 
tive 1 1-24-70 (Register 70. No. 418). 

2. Certificate of Compliance— Sec. 1 1422.1, Gov. Code, filed 1-20-71 (Register 
71, No. 4). 

3. Amendment of subsection (a) filed 6-8-72; effective thirtieth day thereafter 
(Register 72, No. 24). 

§ 1034. Certification of Phlebotomy Technicians. 

(a) The education, training and experience required for certification in 
phlebotomy shall be as follows: 

( 1 ) For a person to be eligible for certification as a Limited Phlebotomy 
Technician, he or she shall: 

(A) Be a high school graduate or have achieved a passing score on the 
general educational development (GED) test or documentation of equiv- 
alent education pursuant to Section 1031 .4(c)(6)(B); and 

(B) Have completed a minimum of 20 hours basic didactic instruction 
pursuant to Section 1035.1(e)(1) from a phlebotomy training program 
approved by the department; and 

(C) Have completed a minimum of 25 skin punctures, performed pur- 
suant to the Business and Professions Code Section 1220(d)(1) or 
(d)(2)(A) that fulfill all sampling requirements of all clinical laboratory 
tests or examinations, in a clinical setfing on patients, under the supervi- 
sion of a licensed physician and surgeon, licensed physician assistant, li- 
censed clinical laboratory bioanalyst, registered nurse, or licensed clini- 
cal laboratory scientist, who will certify in writing with a signed 
certificate that this training has been completed; and 

(D) Apply to the department for cerUfication as a Limited Phlebotomy 
Technician pursuant to Section 1031.4(c). 

(2) For a person with no on-the-job experience in phlebotomy to be 
eligible for cerUfication as a Certified Phlebotomy Technician L he or she 
shall: 

(A) Be a high school graduate, or have achieved a passing score on the 
general educational development (GED) test or documentation of equiv- 
alent education pursuant to Section 1031.4(c)(6)(B); and 

(B) Have completed a minimum of 40 hours didactic instruction pur- 
suant to Section 1035.1(e) from a phlebotomy training program ap- 
proved by the department; and 



(C) Have completed a minimum of 40 hours practical instruction from 
a phlebotomy training program approved by the department pursuant to 
Section 1035.1(f), which instruction shall include completion of a mini- 
mum of 10 skin punctures performed pursuant to the Business and Pro- 
fessions Code Section 1 220(d)( 1 ) or (d)(2)(A) that fulfill all sampling re- 
quirements of all clinical laboratory tests or examinations and 50 
venipunctures performed pursuant to the Business and Professions Code 
Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of 
all clinical laboratory tests or examinations; and 

(D) Have passed a written examination in phlebotomy administered 
by a certifying organization approved by the department pursuant to Sec- 
tion 1031.7; and 

(E) Apply to the department for certification as a Certified Phlebotomy 
Technician I pursuant to Section 1031.4(c). 

(3) For a person who has less than 1040 hours on-the-job experience 
in phlebotomy to be eligible for certification as a Certified Phlebotomy 
Technician I, he or she shall: 

(A) Be a high school graduate or have achieved a passing score on the 
general educational development (GED) test or documentation of equiv- 
alent education pursuant to Section 1031.4(c)(6)(B); and 

(B) Have completed a minimum of 40 hours didactic instruction pur- 
suant to Section 1035.1(e) from a phlebotomy training program ap- 
proved by the department; and 

(C) Have a letter signed by a licensed physician and surgeon or li- 
censed clinical laboratory bioanalyst directing the laboratory employing 
the person attesting his or her completion of a specified number of hours 
of on-the-job experience in phlebotomy within the previous five years, 
which shall include the activities listed in Section 1035.1(f) and comple- 
tion of a minimum of 10 skin punctures performed pursuant to the Busi- 
ness and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all 
sampling requirements of all clinical laboratory tests or examinations 
and 50 venipunctures performed pursuant to the Business and Profes- 
sions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling re- 
quirements of all clinical laboratory tests or examinations; and 

(D) Have passed a written examination in phlebotomy administered 
by a certifying organization approved by the department pursuant to Sec- 
tion 1031.7; and 

(E) Apply to the department for certification as a Certified Phlebotomy 
Technician I pursuant to Section 1031.4(c). 

(4) For a person who has 1 040 hours or more of on-the-job experience 
in phlebotomy to be eligible for certification as a Certified Phlebotomy 
Technician I, he or she shall: 

(A) Be a high school graduate or have achieved a passing score on the 
general educational development (GED) test or documentation of equiv- 
alent education pursuant to Section 1031.4(c)(6)(B); and 

(B) Have completed a minimum of 20 hours advanced didactic 
instruction pursuant to Section 1035.1(e)(2) from a phlebotomy training 
program approved by the department; and 

(C) Have a letter signed by a licensed physician and surgeon or li- 
censed clinical laboratory bioanalyst directing the laboratory employing 
the person attesting his or her completion of a specified number of hours 
of on-the-job experience in phlebotomy within the previous five years 
which shall include the activities listed in Section 1035.1(f) and comple- 
tion of a minimum of 10 skin punctures performed pursuant to the Busi- 
ness and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all 
sampling requirements of all clinical laboratory tests or examinations 
and 50 venipunctures performed pursuant to the Business and Profes- 
sions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling re- 
quirements of all clinical laboratory tests or examinations; and 

(D) Have passed a written examination in phlebotomy administered 
by a certifying organization approved by the department pursuant to Sec- 
tion 1031.7; and 

(E) Apply to the department for certification as a Certified Phlebotomy 
Technician I pursuant to Section 1031.4(c). 

(5) For a person to be eligible for certification as a Certified Phleboto- 
my Technician H, he or she shall: 



Page 20.8 



Register 2005, No. 37; 9-16-2005 



Title 17 



State Department of Health Services 



§ 1034.2 



(A) Be a Certified Phlebotomy Technician I who holds a current, valid 
certificate from the department or who meets certification requirements 
as a Certified Phlebotomy Technician I pursuant to Section 
1034(a)(4)(A)-(D) and who has at least 1040 hours on-the-job experi- 
ence in phlebotomy in the previous 5 years as certified in writing by the 
director(s) of the laboratory(ies) employing the person; and 

(B) Have completed a minimum of 20 arterial punctures performed 
pursuant to the Business and Professions Code ^Section 1220(d)(1) or 
(d)(2)(A) that fulfill all sampling requirements of all clinical laboratory 
tests or examinations and performed under the general overall responsi- 
bility of a licensed physician and surgeon, licensed physician assistant, 
licensed clinical laboratory bioanalyst, registered nurse, respiratory care 
practitioner or a licensed clinical laboratory scientist, who will certify in 
writing that this person has completed this practical instruction; and 

(C) Apply to the department for certification as a Certified Phleboto- 
my Technician II pursuant to Section 1031.4(c). 

(b) Performance of phlebotomy by a person certified by the depart- 
ment shall be limited as follows: 

( 1 ) A Limited Phlebotomy Technician shall perform skin punctures 
only when he or she: 

(A) Maintains a current, valid certification with the department as a 
Limited Phlebotomy Technician; and 

(B) Performs skin punctures under the supervision of a licensed physi- 
cian and surgeon, licensed physician assistant, licensed clinical laborato- 
ry bioanalyst, registered nurse, licensed clinical laboratory scientist or a 
designee. A designee shall be licensed or certified under Chapter 3 and 
shall be accountable to the laboratory director for skin punctures and oth- 
er duties related to blood collection performed by the Limited Phleboto- 
my Technician. The supervisor shall review the work of the technician 
at least once a month and be accessible to the location where the techni- 
cian is working to provide on-site, telephone, or electronic consultation 
when blood is being collected; and 

(C) Ls shown to be competent to perform skin punctures after employ- 
ment without direct and constant supervision before being allowed to 
perform skin puncture on patients. Documentation of competency shall 
be done at least annually; and 

(D) Has completed at least three hours per year, or six hours every two 
years, of continuing education in phlebotomy related courses from a pro- 
vider of continuing education approved pursuant to Article 2.5; and 

(E) Has posted at the work location in the laboratory employing the 
person, a current, valid state certificate as a Limited Phlebotomy Techni- 
cian. When performing skin punctures away from the posted location, the 
Limited Phlebotomy Technician shall carry a current, valid identification 
card issued by the department attesting the person's name, certificate 
type and effective dates of certification as a Limited Phlebotomy Techni- 
cian. 

(2) A Certified Phlebotomy Technician I shall perform skin punctures 
and venipunctures only when he or she: 

(A) Maintains a current, valid certification with the department as a 
Certified Phlebotomy Technician I; and 

(B) Performs skin punctures and venipunctures under the supervision 
of a licensed physician and surgeon, licensed physician assistant, li- 
censed clinical laboratory bioanalyst, registered nurse, licensed clinical 
laboratory scientist or a designee. A designee shall be a person licensed 
or certified under Chapter 3 and shall be accountable to the laboratory di- 
rector for skin punctures, venipunctures and other duties related to blood 
collection performed by the Certified Phlebotomy Technician L The su- 
pervisor shall review the work of the technician at least once a month and 
be accessible to the location where the technician is working to provide 
on-site, telephone, or electronic consultation as needed; and 

(C) Is shown to be competent to perform skin puncture and venipunc- 
ture after employment without direct and constant supervision before be- 
ing allowed to perform skin punctures or venipunctures on patients. Doc- 
umentation of competency shall be done at least annually; and 



(D) Has completed at least three hours per year, or six hours every two 
years, of continuing education in phlebotomy related courses from a pro- 
vider of continuing education approved pursuant to Article 2.5; and 

(E) Has posted at the work location of the laboratory employing the 
person, a current, valid state certificate as a Certified Phlebotomy Tech- 
nician I. When performing skin punctures or venipunctures away from 
the posted location, the Certified Phlebotomy Technician I shall carry a 
current, valid identification card issued by the department attesting the 
person's name, certificate type and effective dates of certification as a 
Certified Phlebotomy Technician I. 

(3) A Certified Phlebotomy Technician II shall perform skin punctures 
and venipunctures only under conditions pursuant to Section I ()34(b)(2), 
and shall be limited to performing arterial punctures only when a licensed 
physician and surgeon, Hcensed physician assistant, licensed clinical lab- 
oratory bioanalyst, registered nurse, licensed clinical laboratory scientist 
or a respiratory care practitioner is present at the location during perfor- 
mance of an arterial puncture, and when he or she: 

(A) Maintains a current, valid certification with the department as a 
Certified Phlebotomy Technician II; and 

(B) Is shown to be competent to perform arterial punctures after em- 
ployment by direct, personal observation and documentation of his or her 
expertise in arterial punctures by a licensed physician and surgeon, li- 
censed physician assistant, licensed clinical laboratory bioanalyst, regis- 
tered nurse, licensed clinical laboratory scientist or a respiratory care 
practitioner. Documentation of competency shall be done at least annual- 
ly; and 

(C) Has completed at least three hours per year, or six hours every two 
years, of continuing education in phlebotomy related courses from a pro- 
vider of continuing education approved pursuant to Article 2.5; and 

(D) Has posted at the work location in the laboratory employing the 
person, a current, valid state certificate as a Certified Phlebotomy Tech- 
nician II. When performing arterial punctures, skin punctures, or veni- 
punctures away from the posted location, the Certified Phlebotomy 
Technician II shall carry a current, valid identification card issued by the 
department attesting the person's name, certificate type and effective 
dates of certification as a Certified Phlebotomy Technician II. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1220, 
1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 
120580, Health and Safety Code. 

History 
\. Amendment filed 7-2-73 as an emergency; effective upon filing (Register 73, 
No. 27). For prior history, see Register 72, No. 32. 

2. Certificate of Compliance filed 10-24-73 (Register 73, No. 43). 

3. Amendment filed 1-18-74; effective thirtieth day thereafter (Register 74, No. 
3). 

4. Amendment filed 1 2-1 2-75; effective thirtieth day thereafter (Register 75, No. 
50). 

5. Repealer and new section filed 1-9-2003; operative 4-9-2003 (Register 2003, 

No. 2). 

§ 1034.1. Unlicensed Personnel, Laboratory Aides. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: SecUon 1224, Business and Profes- 
sions Code; and Section 100275, Health and Safety Code. 

History 

1. New secfion filed 6-8-72; effective thirtieth day thereafter (Register 72, No. 
24). 

2. Repealer of section and new Note filed 1-9-2003; operative 4-9-2003 (Regis- 
ter 2003, No. 2). 

§ 1034.2. Unlicensed Personnel, Cytotechnologist. 

NOTE: Authority cited: Secfion 1224, Business and Professions Code; Section 
208, Health and Safety Code. Reference: Secfion 1270, Business and Professions 
Code; Section 1002, Health and Safety Code. 

History 
1. Amendment filed 12-12-78; effecfive thirtieth day thereafter (Register 78, No. 
50). For prior history, see Register 74, No. IH. 



Page 20.9 



Register 2005, No. 37; 9-16-2005 



§ 1035 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



2. Repealer filed 1 1-18-93 as an emergency; operative 11-18-93 (Register 93, 
No. 47). A Certificate ofCompliance must be transmitted toOAL by 3-18-94 
or emergency changes will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 1 1-18-93 order transmitted to OAL 3-18-94 
and filed 4-29-94 (Register 94, No. 17). 



Article 2. Training 



§1035. Training Schools. 

(a) Any person operating a school or conducting any course for the 
purpose of training or preparing individuals for a license under the provi- 
sions of Chapter 3, Division 2 of the Business and Professions Code shall 
submit, on forms provided by the department and subject to periodic re- 
newal, such information as may be required by the department to satis- 
factorily evaluate the personnel, equipment, quality of instruction, and 
scope of activities of said schools. 

(b) Persons providing instruction in general or specialized technic 
shall provide training which when successfully completed will fully 
qualify individuals to meet the minimum requirements for licensure un- 
der the provisions of Article 4, Chapter 3, Division 2 of the Business and 
Professions Code. 

(c) A training school shall accept a person licensed for training in clini- 
cal laboratory procedures only if there are on active duty in the laboratory 
a minimum of two full-time actively employed persons who possess any 
of the following licenses: clinical laboratory technologist, clinical labo- 
ratory bioanalyst, physician and surgeon, or appropriate laboratory spe- 
cialty. 

(d) The ratio of licensed clinical laboratory personnel to trainees shall 
be no less than 2:1. 

(e) The following shall be minimum requirements for approval of lab- 
oratories to employ clinical laboratory technologist trainees as provided 
for in Article 2 of Chapter 3, Division 2 of the Business and Professions 
Code: 

( 1 ) There shall be adequate space and necessary equipment as defined 
by the department to carry out the procedures of the laboratory and to pro- 
vide training for the clinical laboratory technologist trainees. 

(2) The workload of the laboratory training clinical laboratory tech- 
nologist trainees shall meet minimum standards set by the department 
and shall include at least the following: routine chemical determinations 
commonly required on blood, spinal fluid, and other body fluids; mor- 
phological, cultural, chemical and immunological tests for microbial 
pathogens; tests for helminths and protozoa; examinations for normal 
and abnormal blood cells; sedimentation rates, bleeding and coagulation 
time determinations and other commonly employed tests in hematology; 
precipitation, flocculation, agglutination or complement fixation tests; 
blood typing, Rh factor determinations and pretransfusion procedures; 
commonly employed serological tests; routine and microscopic urinaly- 
ses and such other technics as may be required to properly instruct clini- 
cal laboratory technologist trainees in current clinical laboratory proce- 
dures. 

(3) The amount of practical training required by each clinical laborato- 
ry technologist trainee in order to fulfill the minimum requirements for 
admission to the licensing examinations shall be in accordance with the 
provisions of Article 4, Chapter 3, Division 2 of the Business and Profes- 
sions Code. When one year of practical training in all subjects is neces- 
sary, the minimum time devoted to each shall be as follows: 

Biochemistry 12 Weeks 

Hematology 8 Weeks 

Pretransfusion Procedures 4 Weeks 

Urinalysis 4 Weeks 

Bacteriology 9 Weeks 

Serology 4 Weeks 

Parasitology 3 Weeks 

Miscellaneous and review 8 Weeks 

(4) When less than one or more than one year of practical training is 
required toward admission to the clinical laboratory technologists' ex- 
amination, the above time devoted to the various subjects shall be de- 



creased or increased proportionately after the laboratory director has se- 
cured approval from the department for the modification. 

(5) However, when one or more years of practical training in any one 
basic science or specialty is necessary, the laboratory director shall 
modify this schedule, subject to prior approval by the department, so that 
the area of concentration is in one or more subjects. 

(6) Unless a trainee is a college graduate, he must receive during the 
course of his training program a minimum of 40 clock hours of recitation 
or instruction in the subjects covered in clinical laboratory work other 
than that received as practical training in the laboratory. Any laboratory 
school approved for specialist or limited technologist training must pro- 
vide the department with adequately documented workload and program 
information and must comply with the minimum requirements hereto- 
fore stated in that special field of training. 

(7) The requirements for the members of the teaching staff must be 
those considered minimum for licensure, and in addition, persons with 
an advanced degree in one or more of the fields covered in the curriculum 
may be included on the teaching staff. 

(8) The director of any school shall supply sufficient information to the 
department to satisfy the department that adequate specimen material 
will be made available for training purposes. 

(9) There shall be available to persons receiving training a technical 
library adequate in the number of copies of each text book. 

(10) The names and addresses of persons receiving training are to be 
reported to the department at the time of entrance to course and again at 
completion of course. 

(11) The department may require such other information as may be 
necessary to satisfactorily evaluate the application for approval includ- 
ing periodic on-site reviews. 

(12) Approval for training granted by the department pursuant to re- 
quirements of this section may be denied or withdrawn if the school is 
unable to meet or maintain these requirements. 

(f) Colleges or universities accredited by the Western College Associ- 
ation or the Northwest Association of Secondary and Higher Schools or 
an essentially equivalent accrediting agency, as determined by the de- 
partment, conducting courses for the purpose of training or preparing 
persons for a license under the provisions of Chapter 3, Division 2 of the 
Business and Professions Code, shall be considered approved by the de- 
partment. Provided, however, that when such training is carried out in 
cooperation with other laboratories than those of said institutions, specif- 
ic approval shall be obtained. 

History 

1 . Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No. 
18). 

2. Amendment filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 
21). 

3. Amendment filed 5-18-64; effective thirtieth day thereafter (Register 64, No. 
11). 

4. Repealer and new section filed 12-28-71; effective thirtieth day thereafter 
(Register 72, No. 1). 

§ 1035.1. Phlebotomy Training Program Requirements. 

(a) In order to be eligible for approval by the department to provide di- 
dactic and/or practical phlebotomy instruction leading to certification of 
phlebotomists, a phlebotomy training program shall meet the require- 
ments of this section and be offered by either a: 

(1) National Accrediting Agency for Clinical Laboratory Sciences 
(NAACLS) approved program for training phlebotomists; or 

(2) Accredited college or university; or 

(3) Private, post-secondary program or occupational program regis- 
tered or approved by the Bureau for Private Postsecondary and Vocation- 
al Education; or 

(4) California Adult Education or Regional Occupational Program 
(ROP); or 

(5) United States of America military medical laboratory specialist 
program; or 

(6) California licensed clinical laboratory. 



Page 20.10 



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Title 17 



State Department of Health Services 



§ 1035.1 



(b) A phlebotomy training program shall be directed by a licensed phy- 
sician and surgeon, licensed physician assistant, registered nurse, or per- 
son licensed under Chapter 3, who shall be responsible for: 

( 1 ) Overall operation and administration of the phlebotomy training 
program; and 

(2) Ensuring the quality of the technical, scientific and clinical instruc- 
tion; and 

(3) Ensuring that the person(s) providing instruction meets the qualifi- 
cations of this section; and 

(4) Ensuring that the person(s) providing instruction is competent and 
that his or her work performance is periodically evaluated, monitored and 
documented. 

(c) The person(s) providing instruction shall be a: 

(1) Licensed physician and surgeon; or 

(2) Licensed physician assistant; or 

(3) Registered nurse; or 

(4) Person licensed under Chapter 3; or 

(5) Respiratory care practitioner with a minimum of 2 years experi- 
ence in the previous 5 years; or 

(6) Certified phlebotomy technician with a minimum of 3 years of ex- 
perience in the previous 5 years or a phlebotomist with 3 years of experi- 
ence in the previous 5 years and employed as a phlebotomy instructor, 
who shall meet certification requirements pursuant to Section 1034(a)(4) 
on or before December 31, 2003. 

(d) Person(s) specified in Subsection (c)(1) through (5) shall pass a 
written examination in phlebotomy, administered by a certifying orga- 
nization approved by the department pursuant to Section 1031.7 either: 

( 1 ) Prior to employment by a phlebotomy training program approved 
by the department pursuant to this section; or 

(2) No later than December 31, 2003, if employed as a phlebotomy 
instructor on or before April 9, 2003. 

(e) An approved phlebotomy training program shall provide the fol- 
lowing didactic instruction to its students: 

( 1 ) A basic phlebotomy curriculum consisting of a minimum of 20 
hours lecture and testing for knowledge of: 

(A) Basic infection control, universal precautions and safety; and 

(B) Basic anatomy and physiology of body systems with emphasis on 
the circulatory system, the appropriate medical terminology; and 

(C) Proper identification of patient and specimens, the importance of 
accuracy in overall patient care; and 

(D) Proper selection and preparation of skin puncture site, including 
selection of antiseptic; and 

(E) Blood collection equipment, types of tubes and additives, proper 
order of draw when additives are required, special precautions; and 

(F) Post-puncture care; and 

(G) Appropriate disposal of sharps, needles and waste. 

(2) An advanced phlebotomy curriculum consisting of a minimum of 
20 hours of lecture and testing for knowledge of: 

(A) Advanced infectious disease control and biohazards; and 

(B) Anti-coagulation theory; and 

(C) Knowledge of pre-analytical sources of error in specimen collec- 
tion, transport, processing and storage; and 

(D) Anatomical site selection and patient preparation; and 

(E) Risk factors and appropriate responses to complications which 
may arise from phlebotomy; and 

(F) Recognition of, and corrective actions to take, with problems in 
test requisitions, specimen transport and processing; and 

(G) Applications of basic concepts of communication, interpersonal 
relations, stress management, professional behavior, ethics and legal im- 
plications of phlebotomy; and 

(H) Quality assurance in phlebotomy necessary to provide accurate 
and reliable laboratory test results; and 
(I) Legal issues related to blood collection. 

(f) An approved phlebotomy training program shall provide a clinical 
setting for a minimum of 40 hours of practical instruction in phlebotomy. 



This setting shall provide access to patients whose blood is being tested 
by a clinical laboratory. In order for a program to be eligible for approval 
by the department, it shall provide documentation of a training curricu- 
lum that includes: 

(1) Selection of blood collection equipment appropriate to test requisi- 
tions; and 

(2) Preparation of the patient and infection control; and 

(3) Skin punctures for testing purposes from patients of varying ages, 
including pediatric and geriatric, and of varying health and obesity status; 
and 

(4) Venipunctures from patients of varying ages, health and obesity 
status; and 

(5) Post-puncture care; and 

(6) Processing of blood containers after collection, including centrifu- 
gation; and 

(7) Proper disposal of needles, sharps and medical waste; and 

(8) Observation of arterial punctures; and 

(9) A practical examination showing evidence of successful comple- 
tion of Subsections (f)(1) through (7). 

(g) A phlebotomy training program shall be responsible for assuring 
that a student completes a minimum of 10 skin punctures performed pur- 
suant to the Business and Professions Code Section 1220(d)(1) or 
(d)(2)(A) that fulfill all sampling requirements and 50 venipunctures per- 
formed pursuant to the Business and Professions Code Section 
1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clini- 
cal laboratory tests or examinations during or after his or her practical 
instruction. 

(h) A phlebotomy training program shall provide a certificate of 
completion to its students upon satisfactory completion of the program. 
The program shall maintain a copy of this certificate for five years. This 
certificate shall be signed by the director of the program and shall in- 
clude: 

(1) Name and address of the training program; and 

(2) Name of the student; and 

(3) Statement of satisfactory completion of the program; and 

(4) Dates that training began and ended. 

(i) A phlebotomy training program seeking approval from the depart- 
ment shall provide documentation to substantiate that its program objec- 
tives meet training criteria stated in this section. Verification may include 
an on-site inspection of the program. 

(j) A complete application for phlebotomy training program approval 
shall include the following: 

( 1 ) Name and address of the training program; and 

(2) Location(s) of all sites where didactic and practical instruction oc- 
cur; and 

(3) Name(s) and license number(s) of the physician and surgeon, phy- 
sician assistant, registered nurse, or person licensed under Chapter 3 who 
is directing the program; and 

(4) Name(s), license number(s) or certificate number(s), experience in 
phlebotomy, and evidence of satisfactory performance on a phlebotomy 
certification examination administered by a certifying organization with 
departmental approval in effect at the time the examination was adminis- 
tered, of every physician and surgeon, physician assistant, registered 
nurse, person licensed under Chapter 3, respiratory care practitioner, cer- 
tified phlebotomy technician, or phlebotomist pursuant to Subsection 
(c)(6) who is supervising or providing instruction; and 

(5) List of equipment, supplies and educational materials used for 
instruction; and 

(6) Curriculum and instructional objectives, including hours spent at 
each activity. 

(k) Timeframes for approval of training programs shall be as follows: 

( 1 ) Submission of an application for approval shall be deemed to occur 
on the date the complete application is received by the department. 

(2) Written notification by the department to the applicant shall be 
considered to occur on the date the documents are postmarked. 



Page 20.11 



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§ 1035.3 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(3) The department shall notify the applicant within 60 days ofsubmis- 
sion of an application for training program approval, of one of the follow- 
ing: 

(A) That the application is complete and acceptable for processing by 
the department; or 

(B) That the application is incomplete and not accepted for processing. 
This notification shall include the specific information or documentation 
that the applicant shall submit within 30 days in order for the department 
to consider the application acceptable; or 

(C) That the application has been reviewed and does not meet the re- 
quirements of this section and that approval is denied. 

(4) The department shall consider an application to have been aban- 
doned by any applicant who fails to respond to the department's request 
to submit specific information or documentation within 30 days of notifi- 
cation pursuant to Section 1035.!(k)(3)(B). 

(5) The department's time periods for processing an application, from 
the date the initial application is received to the date the final decision is 
made regarding approval, are as follows: 

(A) The median time for processing an application is 90 days. 

(B) The minimum time for processing is 30 days. 

(C) The maximum time for processing is 150 days. 
(/) Approval shall be valid for a two-year period. 

(m) To apply for renewal, a training program shall file a renewal ap- 
plication at least 60 days prior to the end of the approval period and pro- 
vide the following: 

( 1 ) The name and address of the training program; and 

(2) The name and license number of all directors; and 

(3) The name, license or certificate number of all instructors; and 

(4) The name(s) and location(s) of all didactic and practical instruc- 
tion; and 

(5) The curriculum and instructional objectives, including hours spent 
at each activity; and 

(6) The schedule of didactic and practical instruction for the next 24 
months; and 

(7) The listing of students who completed its program and the total 
number of students who enrolled in its program in the previous approval 
period; and 

(8) The signature of the director(s) and date of the application for re- 
newal. 

(n) Failure to meet the requirements of this section shall be good cause 
for denial or revocation of approval by the department. 

(0) The training program shall notify the department in writing of any 
change(s) in the information and material required by Subsections (a) 
through (h) within 30 days after the change(s) has occurred. 

NOTE: Authority cited: Sections 1224 and 1320, Business and Professions Code; 
and Section 100275, Health and Safety Code. Reference: Sections 1208, 1220, 
1222, 1222.5, 1242, 1242.5, 1246, 1269 and 1300, Business and Professions Code; 
and Section 120580, Health and Safety Code. 

History 
1 . New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2). 

§ 1035-3. Medical Laboratory Technician Training Program 
Standards. 

(a) In order to be eligible for approval by the department, a medical 
laboratory technician training program shall be offered by either a: 

(1) California licensed clinical laboratory; or 

(2) Accredited college or university in the United States of America; 
or 

(3) United States of America military medical laboratory specialist 
program of at least 26 weeks duration; or 

(4) Laboratory owned and operated by the United States of America. 

(b) The program director of a medical laboratory technician training 
program shall be a physician and surgeon licensed under Chapter 5, or 
a doctoral scientist, clinical laboratory bioanalyst, clinical laboratory sci- 
entist or clinical laboratory specialist licensed under Chapter 3. The pro- 
gram director shall be responsible for the content, quality and conduct of 
the training program and shall: 



( 1 ) Employ instructors who are physicians and surgeons licensed un- 
der chapter 5; doctoral scientists, clinical laboratory bioanalysts, clinical 
laboratory scientists, or clinical laboratory specialists licensed under 
chapter 3; medical laboratory technicians with five years practical expe- 
rience licensed under Chapter 3; or public health microbiologists certi- 
fied pursuant to Health and Safety Code Section 101 160. 

(2) Assure that training includes at least 26 weeks, consisting of at least 
1040 hours, of instruction and practical experience in moderate complex- 
ity testing in chemistry, including routine chemistry, urinalysis, endo- 
crinology and toxicology: hematology; microbiology, including bacteri- 
ology, mycobacteriology, mycology, parasitology and virology; and 
immunology, including syphilis serology and general immunology. The 
training shall include at least 160 hours each in chemistry, hematology, 
microbiology and immunology. 

(3) Provide didactic training in: 

(A) Pre-analytical skills including phlebotomy, specimen processing, 
reagent preparation, and infection control, as specified in Secfion 
1035.1(e) and (f); and 

(B) Analytical skills required for performing tests of waived or moder- 
ate complexity, including quality control, test calibration, quality assur- 
ance, legal requirements for documentation of testing, data storage and 
retrieval, safety and standard precautions, troubleshooting, preventive 
maintenance, reagent preparafion and storage; and 

(C) Post-analytical skills such as knowledge of factors that influence 
test results and the ability to access and verify the validity of patient test 
results through review of quality control values prior to reporting patient 
test results; and 

(D) Test methods commonly used in chemistry, hematology, micro- 
biology and immunology, including clinical significance of test results, 
how the tests interrelate and how the tests impact diagnosis and treat- 
ment, quality assessment of test results, information processing and regu- 
latory compliance in state and federal law. 

(4) Provide practical training in: 

(A) Phlebotomy that shall include 40 hours instruction and successful 
completion of a minimum of 10 skin punctures and 50 venipunctures, as 
specified in Section 1035.1(f); and 

(B) Instruction and practical experience in the use of instruments; and 

(C) Preventive maintenance and problem solving malfunctions of 
instruments; and 

(D) Knowledge of instrument and test parameters to assess reason- 
ableness of results; and 

(E) Validation of moderate complexity test methods and clinical cor- 
relation of test results. 

(c) A medical laboratory technician training program shall provide a 
certificate of completion to its students upon satisfactory completion of 
the program. The program shall maintain a copy of this certificate for at 
least five years. This certificate shall be signed by the director of the pro- 
gram and shall include: 

(1) Name and address of the training program; and 

(2) Name of the student; and 

(3) Statement of satisfactory completion of the program; and 

(4) Dates that training began and ended. 

(d) A program approved to train medical laboratory technicians shall 
maintain records of its students for at least five years and shall make 
available to the department documentation of the students successfully 
completing their training. 

(e) A medical laboratory technician training program seeking approv- 
al from the department shall provide documentation to substantiate that 
its program objectives meet training criteria stated in this section. 

(f) A medical laboratory technician training program shall be allowed 
to document program compliance with the requirements of this section 
for a period dating up to four years prior to their initial application, after 
the date of implementation of these standards. The program shall docu- 
ment that, during the time preceding initial approval, the training pro- 
gram met the standards pursuant to Section 1035.3(a) and (b). 



Page 20.12 



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Title 17 



State Department of Health Services 



§ 1036 



(g) A complete application for a medical laboratory technician train- 
ing program shall include the following: 

( 1 ) The name and address of the primary training program, including 
city, state, county and zip code; telephone number, FAX number and e- 
mail address; and 

(2) The location(s) of all sites where training will be conducted, in- 
cluding city, stale and zip code; and 

(3) The name{s) and qualifications of the person(s) directing and 
instructing in the program including a copy of current licensure for each 
person. Training programs in the United States of America but outside 
California shall provide evidence that the director(s) and instructor(s) 
substantially meet this licensure requirement by documenting inclusion, 
licensure or certification in a class of personnel similar to those required 
in Chapter 3 or requiring equivalent standards; and 

(4) Dates the training program was conducted if prior approval is re- 
quested as specified in Section 1035.3(f); and 

(5) The didactic curriculum listing each class or topic with instruction- 
al objectives, the instractorCs) and the amount of time allocated for each 
class or topic, pursuant to Section 1035.3(b)(3); and 

(6) Documentation of practical training in pre-analytical, analytical 
and post-analytical skills, including instructor(s) and hours spent at each 
activity, list of equipment, supplies and materials used pursuant to Sec- 
tion 1035.3(b)(4); and 

(7) The signature(s) of the program director(s), telephone number(s) 
and date of application. 

(h) A medical laboratory technician training program approval shall 
be valid for a four-year period. To apply for renewal, the training pro- 
gram shall file an application at least 1 20 days prior to the end of the ap- 
proval period providing the following: 

( 1 ) The name and address of the primary training program, including 
city, state, county and zip code, telephone number, FAX number and e- 
mail address; and 

(2) The name, address, and telephone number(s) of the director(s) and 
instructor(s), providing documentation of their current licensure; and 

(3) Any changes in training locations, didactic and practical instruc- 
tion, course objectives, equipment, supplies and materials, that shall be 
made to the program from that approved in the previous application; and 

(4) A listing of all students who completed its program and the total 
number of students who enrolled in its program during the previous ap- 
proval period; and 

(5) The signature(s) of the program director(s) and the date of applica- 
tion for renewal. 

(i) The training program shall notify the department in writing of any 
change(s) in the information and materials required by Section 1035.3(b) 
through (d) within 30 days after the change(s) has occurred. 

(j) Failure to meet and maintain the requirements of this section shall 
be good cause for denial or revocation of approval by the department. 
NOTE; Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206.5, 1208, 1209, 1222, 
1222.5, 1242, 1246, 1260.3, 1269,1286 and 1300, Business and Professions Code. 

History 

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register 
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by 
5-1 3-2005 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Regis- 
ter 2005, No. 19). A Certificate of Compliance must be transmitted to OAL by 
9-12-2005 or emergency language will be repealed by operation of law on the 
following day. 

3. Certificate of Compliance as to 5-12-2005 order, including amendment of sub- 
section (b)(4)(E). transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 
2005, No. 37). 

§ 1 035.4. Timeframes for Approval of Training Programs. 

(a) Timeframes for approval of training programs to train clinical labo- 
ratory personnel for licensure pursuant to Chapter 3 shall be as follows: 

( 1 ) Submission of an application for approval shall be deemed to occur 
on the date the application is received by the department. 



(2) Written notification by the department to the applicant program 
shall be considered to occur on the date the documents are postmarked. 

(3) The department shall notify the applicant within 60 days of submis- 
sion of an application for training program approval, of one of the follow- 
ing: 

(A) That the application is complete and acceptable for processing by 
the department; or 

(B) That the application is incomplete and not accepted for processing. 
This notification shall include the specific information or documentation 
that the applicant shall submit within 30 days in order for the department 
to consider the application acceptable; or 

(C) That the application has been reviewed and does not meet the re- 
quirements of this section and that approval is denied. 

(4) The department shall consider an application to have been aban- 
doned by any applicant program which fails to respond to the depart- 
ment's request to submit specific information or documentation within 
30 days of notification pursuant to Section 1035.4(a)(3)(B). 

(b) Timeframes for processing applications for renewal of approval to 
train clinical laboratory personnel for licensure pursuant to Chapter 3 
shall be as follows: 

(1) The training program shall submit a renewal application at least 
120 days prior to the end of the approval period. 

(2) Within 30 days of receipt of a renewal application, the department 
shall inform the training program in writing that the application is com- 
plete and accepted for review, or deficient and what specific information 
or documentation is required to complete the applicafion. 

(3) Within 30 days of submitdng a completed renewal application, the 
department shall inform the training program in writing whether its ap- 
plicafion has been approved or denied. 

(4) The department may authorize a training program to extend its ap- 
proval during the fime its application is being reviewed when that train- 
ing program is in good standing and its application was submitted at least 
120 days prior to the end of the approval period. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1261.5, 1263, 1264, 1286 
and 1302, Business and Professions Code. 

History 

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register 
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by 
5-13-2005 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Regis- 
ter 2005, No. 1 9). A Certificate of Compliance must be transmitted to OAL by 
9-12-2005 or emergency language will be repealed by operation of law on the 
following day. 

3. Certificate of Compliance as to 5-12-2005 order, including subsection (b)(2), 
transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37). 



Article 2.3. Clinical Laboratory Supervisors 

§ 1036. Clinical Consultant. 

(a) Every clinical laboratory director, under whom moderate or high 
complexity tests or examinations are performed, shall either perform the 
dufies of a clinical consultant or employ a clinical consultant who can 
provide consultation about the appropriateness of testing ordered and in- 
terpretation of test results, as specified in Section 1 209, chapter 3 of the 
Business and Professions Code. 

(b) The clinical consultant shall possess a current, valid license issued 
by the State to direct a clinical laboratory pursuant to chapter 3, Business 
and Professions Code, or to practice medicine, osteopathy or podiatry 
pursuant to chapter 5, Business and Professions Code appropriate to the 
specialties and subspecialties for which he or she is consulting. 

(c) The clinical consultant shall: 

(1) Provide clinical consultation to the clients of the laboratory; and 

(2) Assist in ordering tests appropriate to meet clinical expectations; 
and 

(3) Ensure that test results include pertinent information required for 
interpretation; and 



Page 20.13 



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§ 1036.1 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(4) Communicate matters about quality of test results reported and in- 
terpretation in relation to specific patient conditions. 
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275. Health and Sattty Code. Reference: Sections 1206, 1207, 1208, 1209, 
1209.1 and 1210. Business and Professions Code. 

History 

1 . New article 2.3 (sections 1 036-1 036.4) and section filed 2-24-2000 as an emer- 
gency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Com- 
pliance must be transmitted to O AL by 6-23 -2000 or emergency language will 
be repealed by operation of law on the follow ing day. For prior history, see Reg- 
ister 72, No. 1. 

2. New article 2.3 (sections 1036-1036.4) and section refiled 6-21-2000 as an 
emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of 
Compliance must be transmitted to OAL by 10-23-2000 or emergency lan- 
guage will be repealed by operation of law on the following day. 

3. New article 2.3 (sections 1036-1036.4) and section refiled 10-19-2000 as an 
emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of 
Compliance must be transmitted to OAL by 2-2 1-200 1 or emergency language 
will be repealed by operation of law on the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
subsections (a) and (b), transmitted to OAL 2-21-2001 and filed 4-3-2001 
(Register 2001, No. 14). 

§ 1036.1. General Supervisor. 

(a) Every clinical laboratory director, under whom high complexity 
tests or examinations are performed, shall either perform the duties of a 
general supervisor or employ a general supervisor who shall be responsi- 
ble for day-to-day supervision of laboratory operation and personnel 
performing and reporting high complexity tests, pursuant to Section 
1209, chapter 3 of Business and Professions Code. 

(b) A general supervisor shall: 

( 1 ) Possess an active, valid license issued by the State to perform high 
complexity testing pursuant to chapter 3 of Business and Professions 
Code or to practice medicine, osteopathy or podiatry pursuant to chapter 
5 of Business and Professions Code appropriate to the specialty or spe- 
cialties they are supervising; and 

(2) Have a minimum of two years' experience in high complexity test- 
ing in the specialty or specialties they are supervising. 

(c) The general supervisor shall be accessible to testing personnel at 
all times testing is performed by providing on-site, telephone or electron- 
ic consultation to resolve technical problems. 

(d) The general supervisor shall be responsible for ensuring that tests 
and examinations are performed in compliance with chapter 3 of the 
Business and Professions Code and Title 42, Code of Federal Regula- 
tions, Part 493 standards as published October 1 , 1 994, regarding clinical 
laboratories. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 
1209.1 and 1210, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New secdon refiled 1 0-1 9-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 

§ 1036.2. Moderate Complexity Laboratory Technical 
Consultant. 

(a) Every laboratory director, under whom moderate complexity tests 
or examinations are performed, shall either perform the duties of a mod- 
erate complexity laboratory technical consultant or employ a moderate 
complexity laboratory technical consultimt who is responsible for pro- 
viding technical and scientific consultation for each of the specialties and 
subspecialties performed. 



(b) A moderate complexity laboratory technical consultant of a labora- 
tory performing moderate complexity testing shall: 

(1) Possess an active, valid license issued by the State pursuant to 
chapter 3 of the Business and Professions Code to perform high complex- 
ity testing, or to practice medicine, osteopathy or podiatry pursuant to 
chapter 5 of Business and Professions Code appropriate to the specialty 
or specialties for which he or she is consulting; and 

(2) Have a minimum of two years' experience in moderate or high 
complexity testing in the specialty or specialties for which he or she is 
consulting. 

(c) A moderate complexity laboratory technical consultant shall be re- 
sponsible for the technical and scientific oversight of the laboratory as 
specified in Section 493. 1413, Title 42, Code of Federal Regulations, as 
published October 1 , 1 994. 

NOTE: Authority cited: Secfion 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 
1209.1 and 1210. Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-19-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order, including amendment of 
subsecfions (a) and (b)(l)-(2), transmitted to OAL 2-21-2001 and filed 
4-3-2001 (Register 2001, No. 14). 

§ 1036.3. Waived Laboratory Supervisor. 

(a) A laboratory director of a clinical laboratory performing waived 
tests may delegate or reapportion his or her responsibilities, as allowed 
by Section 1209 of the Business and Professions Code, by utilizing a 
waived laboratory supervisor. Except for a waived laboratory supervisor 
of a laboratory performing blood glucose testing by a person certified as 
an Emergency Medical Technician 11 or Paramedic pursuant to Division 
2.5 (commencing with section 1797) of the Health and Safety Code and 
pursuant to subsection (c) and (d), a waived laboratory supervisor shall: 

(1) Be Usted in Section 1206.5 of the Business and Professions Code; 
and 

(2) Possess at least a baccalaureate degree from an accredited college 
or university; and 

(3) Have at least one year of training or experience in clinical laborato- 
ry testing in those tests or examinations that he or she will be supervising; 
and 

(4) Document competency in those tests he or she will be supervising 
to the laboratory director at least semiannually during the first year and 
annually, or whenever new instrumentation is added, thereafter. 

(b) Except for a waived laboratory supervisor of a laboratory perform- 
ing blood glucose testing by a person certified as an Emergency Medical 
Technician II or Paramedic pursuant to Division 2.5 (commencing with 
section 1797) of the Health and Safety Code, a waived laboratory super- 
visor shall be responsible for: 

(1) Selecting, in consultation with the laboratory director, the test 
methodology appropriate for clinical use of test results; and 

(2) Establishing a quality control program appropriate for the tests per- 
formed, which follows the test manufacturer' s parameters for acceptable 
levels of analytical performance and ensures that these levels are main- 
tained throughout the entire testing process from initial receipt of the 
specimen through sample analysis and test result reporting; and 

(3) Resolving technical problems and ensuring remedial actions are 
taken and documented whenever test systems deviate from the manufac- 
turer' s established performance specifications; and 

(4) Ensuring patient test results are not reported until all corrective ac- 
tions have been taken and the test system is performing properly; and 



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Title 17 



State Department of Health Services 



§ 1038 



(5) Identifying training needs and assuring that each individual per- 
forming tests receives regular in-service training and education ap- 
propriate for waived testing; and 

(6) Evaluating and documenting that the staff maintain their compe- 
tency to perform test procedures and report tests promptly, accurately 
and proficiently by: 

(A) Directly observing routine test performance, including patient 
preparations (if applicable), specimen handling, processing and testing; 
and 

(B) Monitoring the recording and reporting of test results; and 

(C) Reviewing quality control records and preventive maintenance re- 
cords; and 

(D) Directly observing performance of instrument maintenance and 
function checks; and 

(E) Assessing problem solving skills; and 

(F) Evaluating and documenting the performance of individuals re- 
sponsible for waived testing at least semiannually during the first year the 
individual tests patient specimens. Thereafter evaluations shall be per- 
formed at least annually unless test methodology or instrumentation 
changes (in which case and prior to reporting patient test results, the indi- 
vidual' s performance shall be re-evaluated to include the use of the new 
test methodology or test instrumentation). 

(c) A waived laboratory supervisor of a laboratory performing blood 
glucose testing by a person certified as an Emergency Medical Techni- 
cian II or Paramedic pursuant to Division 2.5 (commencing with section 
1797) of the Health and Safety Code shall: 

(1) Hold a current, active license as an Emergency Medical Techni- 
cian-Paramedic pursuant to Health and Safety Code Section 1797.194, 
as a registered nurse pursuant to Chapter 6 (commencing with Section 
2700) or as a person under Chapter 3 (commencing with Section 1 200) 
authorized to engage in clinical laboratory practice or to direct a clinical 
laboratory; and 

(2) Have at least one year training or experience in blood glucose test- 
ing in the method or procedure that he or she will be supervising. 

(d) The waived laboratory supervisor of a laboratory performing blood 
glucose testing as specified in subsection (c) shall be responsible for: 

( 1 ) Documenting that each individual performing blood glucose is 
competent to perform the test before he or she starts testing and whenever 
new methodologies or technologies are added; and 

(2) Ensuring that manufacturer's instructions for test performance, 
equipment maintenance and quality control are followed; and 

(3) Resolving technical problems and ensuring remedial actions are 
taken and documented whenever test systems deviate from the manufac- 
turer's established performance specifications. 

(e) A waived laboratory technical supervisor shall be accessible to the 
laboratory testing personnel to provide onsite, telephone or electronic 
consultation. The laboratory director of a laboratory performing blood 
glucose testing by a person certified as an Emergency Medical Techni- 
cian II or Paramedic pursuant to Division 2.5 (commencing with section 
1797) of the Health and Safety Code may designate a licensed physician 
and surgeon or an authorized registered nurse at the hospital serving as 
the base hospital to provide such consultation. 

NoTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 
1209.1 and 1210, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000. No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 
10-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 1 0-1 9-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000. No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 



4. Certificate of CompHance as to 10-19-2000 order, including amendment of 
section headina and section, transmitted to OAL 2-21-2001 and filed 
4-3-2001 (Register 2001, No. 14). 

§1036.4. Technical Supervisor. 

(a) Every laboratory director, under whom high complexity tests or ex- 
aminations are performed, shall either perform the duties of a technical 
supervisor or employ a technical supervisor who is responsible for the 
technical and scientific oversight of the laboratory. 

(b) A technical supervisor of a laboratory performing high complexity 
testing shall: 

( 1 ) Possess an active, valid, license issued by the state to perform high 
complexity testing pursuant to chapter 3 of Business and Professions 
Code or to practice medicine, osteopathy or podiatry, pursuant to chapter 
5 of Business and Professions Code appropriate to the specialty or spe- 
cialties for which they are consulting; and 

(2) Meet the experience requirements in Section 493. 1449 of Title 42 
of the Code of Federal Regulations, as published October 1 , 1 994. 

(c) While not required to be on site at all times testing is performed, 
a technical supervisor shall be available to laboratory testing personnel 
at all times to provide either on-site, telephone or electronic consultation. 

(d) A technical supervisor shall be responsible for all the activities 
Hsted in Section 493. 1 45 1 of Title 42 of the Code of Federal Regulations, 
as published October 1, 1994. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Secfions 1206, 1207, 1208, 1209, 
1209.1 and 1210, Business and Professions Code. 

History 

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 
6-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis- 
ter 2000. No. 25). A Certificate of Compliance must be transmitted to OAL by 
1 0-23-2000 or emergency language will be repealed by operation of law on the 
following day. 

3. New section refiled 10-19-2000 as an emergency; operative 1 0-24-2000 (Reg- 
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL 
by 2-21-2001 or emergency language will be repealed by operation of law on 
the following day. 

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL 
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14). 

Article 2.5. Continuing Education 

§1038. Definitions. 

(a) The definitions set forth in subsections b through j inclusive shall 
govern the interpretation of this article. 

(b) "Contact Hour" means the actual time a licensee participates in 
continuing education offered by an approved provider, utilizing the fol- 
lowing conversion standards: 

50-60 minutes = 1 contact hour 

0.1 continuing education unit (CEU) = 1 contact hour 

1 quarter unit - 1 contact hours 

1 semester unit = 15 contact hours 

(c) "Accredited Academic Institution" means an academic institution 
accredited by the Western Association of Schools and Colleges or an ac- 
crediting organization recognized by the Council of Post Secondary Edu- 
cation. 

(d) "Accrediting Agency" means an organization approved by the De- 
partment pursuant to Section 1038.2 which evaluates and grants approval 
to providers of continuing education who comply with the standards of 
that agency, and who are other than those identified in (c) above. 

(e) "Approved Provider" means an accredited academic institution or 
any person or entity offering continuing education who has been ap- 
proved by an accrediting agency. 

(f) "Licensee" means those persons other than clinical laboratory tech- 
nologist trainees licensed pursuant to Chapter 3 (commencing with sec- 
tion 1200) of Division 2 of the Business and Professions Code. 



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§ 1038.1 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(g) "Quarter Unit" and "Semester Unit" means the hours of instruction 
offered by an accredited academic institution which are credited by that 
institution as a quarter unit and semester unit respectively. 

(h) "Active Status" means a current license in good standing which au- 
thorizes the licensee to perform the functions described in this chapter. 

(i) "Inactive Status" means a license which is not in good standing be- 
cause the holder has not completed the continuing education require- 
ments of this article or has voluntarily requested that the license be made 
inactive. 

(j) "Continuing Education Program" means a presentation given by an 
approved provider at a scheduled time or times which conforms to the re- 
quirements of section 1038.3. 

NOTE: Authority cited: Sectionsl224 and 1273. Business and Professions Code; 
and Section 208, Health and Safety Code. Reference: Section 1275, Business and 
Professions Code. 

History 
1. New Article 2.5 (sections 1038-1038.7) and section filed 1-28-94; operative 

1 -28-94 pursuant to Government Code section 1 1 346.2(d) (Register 94, No. 4). 

§ 1038.1. Continuing Education Requirements. 

(a) All persons licensed under Division 2, Chapter 3 of the Business 
and Professions Code, commencing with Section 1 200, whose license is 
in active status shall complete 12 contact hours of continuing education 
each calendar year. All persons licensed with more than one active li- 
cense type pursuant to Division 2, Chapter 3 of the Business and Profes- 
sions Code shall be able to renew all license types after completion of a 
total of 1 2 contact hours of continuing education each calendar year. 

(b) At the time of renewal, each licensee shall provide the Department 
with the date, name and number of contact hours received for each con- 
tinuing education program successfully completed by the licensee in the 
previous calendar year. 

(c) The licensee shall retain continuing education documents received 
from approved providers under Section 1038.4 for a minimum of four 
years. 

(d) A random sample of licensees shall be audited by the Department 
to determine compliance with the continuing education requirement. 
Those licensees selected for audit shall submit to the Department, within 
30 calendar days of notification of selection, a copy of each document 
provided the Hcensee under section 1038.4(c) since the date of last li- 
cense renewal. 

(e) Any licensee who is found to have not successfully completed the 
continuing education requirement of this article will be placed in inactive 
status. The licensee shall have the right to appeal such findings to the De- 
partment. An appeal shall be conducted in compliance with chapter 5 
(commencing with section 1 1500) of Part I of Division 3 of Title 2 of the 
Government Code. 



NOTE: Authority cited: Sections 1224 and 1275, Business and Professions Code; 
and Section 208, Health and Safety Code. Reference: Section 1275, Business and 
Professions Code. 

History 

1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code 
section 11346.2(d) (Register 94, No. 4). 

§1038.2. Accrediting Agencies. 

(a) Any organization seeking approval as an accrediting agency shall 
submit an application to the Department which shall include documenta- 
tion of the following: 

(1) The organization's name, address, and owner(s); 

(2) The organization's structure, function, and philosophy for moni- 
toring the content, quality, and faculty of approved programs; and, 

(3) The person designated by the organization to be responsible for 
overseeing the administration and coordination of all continuing educa- 
tion providers approved by the organization. 

(b) The Department' s review of an accrediting agency shall include an 
evaluation of the following: 

( 1 ) Whether the organization' s philosophy shows an identifiable com- 
mitment to continuing education; 

(2) Whether the organization's mechanism for monitoring the content, 
faculty, education methods, quality, and facilities of approved providers 
meets the criteria of section 1038.3; and, 

(3) Effective mechanisms for responding to complaints about ap- 
proved providers and the ability to take effective action to insure that ap- 
proved providers comply with sections 1038.3 and 1038.4. 

(c) The Department shall approve an organization as an accrediting 
agency and issue an approval upon satisfactory review under subsections 
(a) and (b). Such approval may be subject to special terms as specified 
by the Department. 

(d) Within 30 calendar days of receipt of an application by an organi- 
zation for approval as an accrediting agency, the Department shall inform 
the organization in writing that the application is either complete and ac- 
cepted for review or that it is deficient and what specific information or 
documentation is required to complete the application. 

(e) Within 30 calendar days from the date of filing of a completed 
application, the Department shall inform the applicant organization in 
writing whether the organization has been approved as an accrediting 
agency. 

(f) The Department's time periods for processing an application for 
approval as an accrediting agency, from the receipt of the initial applica- 
tion to the final decision regarding the approval, are as follows: 

(1) The median time for processing is 60 calendar days. 

(2) The minimum time for processing is 45 calendar days. 

(3) The maximum time for processing is 90 calendar days. 



[The next page is 21.] 



Page 20.16 



Register 2005, No. 37; 9-16-2005 



Title 17 



State Department of Health Services 



§ 1038.7 



(g) An accrediting agency sliall maintain for five years and shall make 
available to the Department, the name of each approved provider, the 
title, date, and number of contact hours awarded for each program of- 
fered by its approved providers, and a list of all participants in each pro- 
gram offered. 

(h) An accrediting agency shall be subject to review by the Department 
to determine adherence to requirements of this ardcle. Failure of an ac- 
crediting agency to meet the requirements of this article or its terms of 
approval is good cause for revocation of approval by the Department. 
NOTH: Authority cited: Sections 1224 and 1275, Business and Professions Code; 
and Section 208, Health and Safety Code. Reference: Section 1275, Business and 
Professions Code. 

History 
1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code 
section 1 1.146.2(d) (Register 94. No. 4). 

§1038.3. Approval of Providers. 

(a) An accrediting agency shall approve only providers who offer con- 
tinuing education programs that meet all of the following criteria: 

( 1 ) Use instructors who are competent in subject matter by education, 
training or experience; 

(2) Are a minimum of 50 minutes in duration excluding evaluation by 
participants of the continuing education program; 

(.S) Are relevant to the scope of practice of clinical laboratory science 
and may include education, supervision, and management; 

(4) Have clearly stated, measurable, education objectives; and, 

(5) Use teaching methods which are consistent with the objectives of 
the continuing education program. 

Noi K: Authority cited: Sections 1224 and 1275, Business and Professions Code; 
and Section 208. Health and Safety Code. Reference: Section 1275, Business and 
Professions Code. 

History 
1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code 
section 11 346.2(d) (Register 94, No. 4). 

§ 1038.4. Approved Providers. 

(a) No person or entity shall represent itself as an approved provider 
unless approved by an accrediting agency or unless it is an accredited 
academic institution. 

(b) Approved providers shall issue certificates to participants which 
include: 

(A) The participant's name; 

(B) Contact hours; 

(C) Date of continuing education provided; 

(D) Name and address of both program provider and accrediting 
agency; and, 

(E) Signature of instructor and/or provider or provider designee. 

(c) Accredited academic institutions shall provide certificates to every 
participant upon completion of a continuing education program which 
includes all the information in subsection (b), except the approved pro- 
vider will not be required to issue a certificate when the continuing edu- 
cation program is a regularly scheduled class and documented on a stu- 
dent transcript. 

(d) An approved provider shall maintain an official record verifying 
all participants' attendance at continuing education programs for at least 
four years after the completion date. The provider shall include the par- 
ticipant on the official record of attendance only if the participant's signa- 
ture was obtained at the time of attendance at the program. The official 
record of attendance shall contain the name of the participant and shall 
identify the time, date, location, subject matter, and length of the continu- 
ing education program and shall be provided to the Department upon re- 
quest at no cost to the Department. 

(e) If two or more approved providers jointly provide a continuing 
education program, the providers shall designate the provider responsi- 
ble for keeping records and issuing certificates to participants. 

(f) An approved provider shall evaluate the effectiveness of continu- 
ing education programs to determine whether the program objectives re- 
quired under section 1038.3 subsection (a)(5) were met. This evaluation 



shall include a written evaluation by the participants, or pre- and post- 
examination. 

(g) An approved provider shall allow, at no cost, in-pcrson observa- 
tion of continuing education programs by employees of the Depai'tment 
of Health Services for purposes of monitoring compliance with sections 
1038.3 and 1038.4. 

NOTE: Authority cited: Sections 1224 and 1275, Business and Professions Code; 
and Section 208, Health and Safety Code. Reference: Section 1275, Business and 
Professions Code. 

History 
1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code 

section 1 1346.2(d) (Register 94, No. 4). 

§1038.5. Waiver of Requirement. 

(a) At the time of making application for renewal of a license issued 
pursuant to Division 2, Chapter 3 of the Business and Professions Code 
(BPC), a licensee may request a waiver of all or part of the continuing 
education requirement. To be eligible for a waiver, a license holder shall 
verify in writing that he or she: 

( 1 ) Was residing in another country for at least half the license period 
since the license was issued or, if the license was previously renewed, 
since it was last renewed, and that this reasonably prevented completion 
of the continuing education requirements; or 

(2) Was absent from California for at least half the license period since 
the license was issued or, if previously renewed, since it was last re- 
newed, because of military service, and that this reasonably prevented 
completion of the continuing education requirements; or 

(3) Was prevented from completing the continuing education require- 
ments for reasons of ill health or other good cause, including, but not lim- 
ited, to: 

(A) Total physical and/or mental disability of the licensee for at least 
half of the period since the license was issued or, if previously renewed, 
since it was last renewed; or 

(B) Total physical and/or mental disability of an immediate family 
member for at least half of the period since the license was issued or, if 
previously renewed, since it was last renewed, where the licensee has to- 
tal responsibility for the care of that family member. 

(4) Verification of a disability under paragraph (3) shall include a cor- 
roborating statement by a licensed physician. 

Note-. Authority cited: Sections 1224 and 1275, Business and Professions Code; 
and Section 208, Health and Safety Code. Reference: Section 1275, Business and 
Professions Code. 

History 
1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code 
section 11346.2(d) (Register 94, No. 4). 

§ 1 038.6. inactive Status. 

A licensee whose license issued pursuant to Division 2, Chapter 3 of 
the Business and Professions Code is in inactive status shall document 
12 hours of continuing education for the year prior to reinstatement or 
pass the examination for licensure prior to reinstatement to active status. 
Note: Authority cited: Sections 1224 and 1275. Business and Professions Code; 
and Section 208, Health and Safety Code. Reference: Section 1275, Business and 
Professions Code. 

History 
1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code 

secdon 1 1346.2(d) (Register 94, No. 4). 

§1038.7. Fees. 

(a) A fee of $250.00 shall accompany an application for approval or 
renewal as an accrediting agency. 

(b) At the time of initial application or renewal of a clinical laboratory 
personnel license, an additional fee of $8.00 shall be paid by each licens- 
ee to support the costs of administering and enforcing the continuing edu- 
cation requirements of this article. 

Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; 
and Section 208, Health and Safety Code. Reference: Section 1275, Business and 
Professions Code. 

History 

1. New section filed 1-28-94; operafive 1-28-94 pursuant to Government Code 
secdon 1 1346.2(d) (Register 94, No. 4). 



Page 21 



Register 97, No. 12; 3-21 -97 



§ 1039.1 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Article 2.8. CLIA Certification/State 
Licensure 



§ 1 039.1 . Recognition of CLIA Certification for Limited 
Purpose and Period. 

(a) Except for a certificate of accreditation issued by HHS, a CLIA cer- 
tificate issued to a clinical laboratory that on December 31,1 995 was not 
required to obtain a stale license pursuant to Section 1241 of Chapter 3, 
shall be considered to be a state license or registration issued pursuant to 
Chapter 3 until such time as CLIA exempt status is obtained, provided 
that the CLIA certificate is for the type and complexity of clinical labora- 
tory tests or examinations performed and that it remains in effect, unsus- 
pended and unrevoked during the entire period covering January 1 , 1 996 
to when CLIA exempt status is granted by HHS. 

(b) A certificate of accreditation issued by HHS to a clinical laboratory 
that on December 31,1 995 was not required to obtain a state license pur- 
suant to Section 1241 of Chapter 3, shall be considered a state license or 
registration issued pursuant to Chapter 3 until such time as the accredita- 
tion body, upon whose accreditation the certificate of accreditation was 
issued by HHS, fails to be approved by the department as having accredi- 
tation standards that are equal to, or more stringent than, state require- 
ments for licensure; and, provided that: 

(1) The certificate of accreditation issued by HHS is for the type and 
complexity of clinical laboratory tests or examinations performed and 
that it remains in effect, unsuspended and unrevoked; and 

(2) After exempt status is obtained, the accredited laboratory pays the 
department the $100 annual certificate of accreditation renewal fee. 

(c) A certificate of waiver issued by HHS, to a clinical laboratory that 
on December 31,1 995 was required to obtain a state license, and that per- 
forms only waived tests, physician performed microscopy, or both, shall 
be considered to be a state registration issued pursuant to Chapter 3 until 
such time as CLIA exempt status is obtained, provided that the certificate 
of waiver remains in effect, unsuspended and unrevoked during the en- 
tire period covering January 1, 1996 to when CLIA exempt status is 
granted by HHS. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275. Health and Safety Code. Reference: Sections 1206, 1220, 1241, 1265, 
1281 and 1288.5, Business and Professions Code. 

History 

1. New article 2.8 (sections 1039.1-1039.3) and section filed 5-28-96 as an emer- 
gency; operative 5-28-96 (Register 96, No. 22). A Certificate of Compliance 
must be transmitted to OAL by 9-25-96 or emergency language will be re- 
pealed by operation of law on the following day. 

2. New article 2.8 (sections 1039.1-1039.3) and section refiled 10-7-96 as an 
emergency, including amendment of subsections (a) and (c); operative 1 0-7-96 
(Register 96, No. 41). A Certificate of Compliance must he transmitted to OAL 
by 2^1-97 or emergency language will be repealed by operation of law on the 
following day. 

3. Certificate of Compliance as to 10-7-96 order, including amendment of subsec- 
tion (b), transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12). 

§ 1039.2. Clinical Laboratory Personnel Requirements. 

(a) All persons performing, supervising, consulting on, or directing 
clinical laboratory tests or examinations m California shall meet the re- 
quirements for performing, supervising, consulting on, or directing labo- 
ratory tests or examinations as set forth in Chapter 3 for the type and com- 
plexity of tests performed and irrespective of whether the clinical 
laboratory is operated under a CLIA certificate or under a state license 
or registration. 

(b) All persons performing, supervishig, consulting on, or directing 
clinical laboratory tests or examinations outside California on biological 
specimens originating in California, and irrespective of whether the clin- 
ical laboratory where the tests or examinations are performed is operated 
under a CLIA certificate or under a state license or registration, shall meet 
all personnel requirements set forth in Chapter 3 for the type and com- 
plexity of testing performed, or shall pro\ ide evidence to the department 



that they substantially meet those requirements by documenting inclu- 
sion, licensure or certification in a class of personnel similar to those re- 
quired in Chapter 3 or requiring equivalent standards. 
NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206, 1206.5. 1209, 1241. 
1244, 1265, 1281 and 1288.5, Business and Professions Code. 

History 

1 . New section filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, 
No. 22). A Certificate of Compliance must be transmitted to OAL by 9-25-96 
or emergency language will be repealed by operafion of law on the following 
day. 

2. New section refiled 1 0-7-96 as an emergency; operative 1 0-7-96 (Register 96. 
No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-97 
or emergency language will be repealed by operation of law on the following 
day. 

3. Certificate of Compliance as to 10-7-96 order, including amendment section, 
transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12). 

§ 1039.3. State Licensure or Approval Required During 
CLIA Exemption. 

All clinical laboratories except those idenUfied in subdivision (b) of 
Section 1241, or in Section 1244 of the Business and Professions Code, 
shall have in effect a state license or state registration, and all public 
health laboratories shall be approved public health laboratories during 
any period for which HHS grants CLIA exempt status for chnical labora- 
tories or public health laboratories licensed, registered or approved by the 
department. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Heahh and Safety Code. Reference: Secdons 1206, 1241, 1244, 1265, 
1281 and 1288.5, Business and Professions Code. 

History 

1. New section filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, 
No. 22). A Certificate of Compliance niust be transmitted to OAL by 9-25-96 
or emergency language will be repealed by operation of law on the following 
day. 

2. New section refiled 10-7-96 as an emergency; operative 10-7-96 (Register 96, 
No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-97 
or emergency language will be repealed by operation of law on the following 
day. 

3. Certificate of Compliance as to 10-7-96 order transmitted to OAL 2-3-97 and 
filed 3-19-97 (Register 97, No. 12). 



Article 3. License 

§ 1 040. Forfeited Licenses. 

(a) No license which has been forfeited for failure to pay the required 
fee shall be reinstated until a written request for reinstatement and all un- 
paid fees have been received by the department. 

(b) If the renewal fee is not paid for five or more years, an examination 
will be required in addition to the requirements of subsection (a) above 
before the license may be reinstated, except as otherwise provided in Di- 
vision 2, Chapter 3. Section 1301 of the Business and Professions Code. 
NOTE: Authority cited: Sections 1 02 and 208, Health and Safety Code. Reference: 
Section 1303, Business and Professions Code. 

History 

1. Amendment filed 2-18-58; effective thirtieth day thereafter (Register 58, No. 
3). 

2. Amendment filed 1 1-25-70 as procedural and organizational; designated effec- 
tive 11-24-70 (Register 70, No. 48). 

3. Certificate of Compliance— Sec. 1 1422.1, Gov. Code, filed 1-20-71 (Register 

71, No. 4). 

§1041. Fee Credits. 

Each clinical laboratory that pays a fee subject to reduction under sub- 
division (u) of Section 1300 of the Business and Professions Code shall 
have any reduction credited against the clinical laboratory's future li- 
cense, registration or other fees payable under Chapter 3. 
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Section 1300, Business and Profes- 
sions Code. 

History 
1 . New section filed 1 1-25-70 as procedural and organizational; designated effec- 
tive 1 1-24-70 (Register 70, No. 48). 



Page 22 



Register 97, No. 12; 3-21-97 



Title 17 



State Department of Health Services 



§ 1050 



2. Certificate of Compliance— Sec. 1 1422.1, Gov. Code, filed 1-20-71 (Register 

71, No. 4). 

3. Amendment of subsection (a) filed 6-5-78; effective thirtieth day thereafter 
(Register78. No. 23). 

4. Repealer filed 4-22-82; effective thirtieth day thereafter (Register 82, No. 17). 

5. New section heading, section and Note filed 5-28-96 as an emergency; opera- 
tive 5-28-96 (Register 96, No. 22). A Certificate of Compliance must be trans- 
mitted to OAL by 9-25-96 or emergency language will be repealed by opera- 
tion of law on the following day. 

6. New section heading, section and Noti-; refiled 10-7-96 as an emergency: op- 
erative 10-7-96 (Register 96, No. 41). A Certificate of Compliance must be 
transmitted to OAL by 2-4-97 or emergency language will be repealed by oper- 
ation of law on the following day. 

7. Certificate of Compliance as to 1 0-7-96 order, including amendment of section, 
transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12). 

§ 1042. Substantial Relationship Criteria. 

Four purposes of denial, suspension or revocation of a license, certifi- 
cate or permit pursuant to Division L5 (commencing with Section 475) 
of the Business and Professions Code, a crime or act shall be considered 
to be substantially related to the qualifications, functions, or duties of a 
person who is an applicant or holder of a license, certificate or permit un- 
der Chapter 3, Division 2, of the Business and Professions Code if to a 
substantial degree it evidences present unfitness of a person holding a li- 
cense, certificate or permit to perform the functions authorized by such 
license, certificate or permit in a manner consistent with the public 
health, safety or welfare. Such crimes or acts shall include but not be lim- 
ited to the following: 

(a) Violating or attempting to violate, directly or indirectly, or assist- 
ing in or abetting the violation of, or conspiring to violate, any provision 
of Chapter 3, Division 2 of the Business and Professions Code. 

(b) Acts of dishonesty, fraud or deceit with intent to substantially bene- 
fit himself or another, or substantially injure another. 

(c) Acts of gross negligence in the performance of functions autho- 
rized by the license, certificate or permit under Chapter 3, Division 2, of 
the Business and Professions Code. 

A license, certificate or permit shall not be denied, suspended or re- 
voked because of a lack of good moral character or any similar ground 
relating to a person's character, reputation, personality or habits. 

NOTE: Authority cited: secfions 208, 3901, 15020 and 25800-25870, Health and 
Safety Code; section 1224, Business and Professions Code. Reference: Secfions 
3901, 15000-15023 and 2581 1, Health and Safety Code; Sections 475, 480, 481, 
482, and 1242.5, Business and Professions Code. 

History 
1 . New section filed 1 2-1 2-75; effective thirtieth day thereafter (Register 75, No. 
50). For former history, see Register 71, No. 4. 

§ 1 042.1 . Criteria for Evaluating Rehabilitation. 

(a) When considering the denial of a license, permit or certificate un- 
der Section 480 of the Business and Professions Code, for which applica- 
tion has been made under Chapter 3, Division 2, of the Business and Pro- 
fessions Code, the Department, in evaluating the rehabilitation of the 
applicant and his present eligibility for a Hcense, permit or certificate, 
shall consider the following criteria: 

( 1 ) The nature and severity of the act(s) or crime(s) under consider- 
ation as grounds for denial. 

(2) Evidence of any act(s) committed subsequent to the act(s) or 
crime(s) under consideration as grounds for denial which also could be 
considered as grounds for denial under Section 480 of the Business and 
Professions Code. 

(3) The time that has elapsed since commission of the act(s) or crime(s) 
referred to in subsection (a) (1) or (a) (2). 

(4) The extent to which the applicant has complied with any terms of 
parole, probation, restitution or any other sanctions lawfully imposed 
upon the applicant. 

(5) Evidence, if any, of rehabilitation submitted by the applicant. 

(b) When considering the suspension or revocation of a license, permit 
or certificate issued under Chapter 3, Division 2 of the Business and Pro- 
fessions Code on the grounds of conviction of a crime, the Department, 



in evaluating the rehabilitation of such person and his present eligibility 
for a license, permit or certificate shall consider the following criteria: 

( 1 ) Nature and severity of the act(s) or offense(s). 

(2) Total criminal record. 

(3) The time that has elapsed since commission of the act(s) or of- 
fense(s). 

(4) Whether the licensee has complied with any terms of parole, proba- 
tion, restitution or any other sanctions lawfully imposed against the li- 
censee. 

(5) If applicable, evidence of expungement proceedings pursuant to 
Section 1203.4 of the Penal Code. 

(6) Evidence, if any, of rehabilitation submitted by the licensee. 

(c) When considering a petition for reinstaiement of a license, permit 
or certificate, the Department shall evaluate evidence of rehabilitation, 
considering those criteria of rehabilitation listed in subsection (h). 
NOTE: Authority cited: Sections 208, 3901. 15020 and 25800-25870, Health and 
Safety Code: Section 1224, Business and Professions Code. Reference: Sections 
3901, 15000-15023 and 2581 1. Health and Safety Code; Secfions 475, 480, 481, 
482 and 1242.5, Business and Professions Code. 

History 
1 . New section filed 12-12-75; effective thirtieth day thereafter (Register 75, No. 

50). 



Article 4. Personnel Report 

§ 1045. Personnel Report. 

All clinical laboratory directors shall on or before December 1 5th of 
each calendar year transmit to the department, on forms provided by the 
department, the names of all persons performing clinical laboratory pro- 
cedures including, but not limited to biochemical, bacteriological, para- 
sitological, hematological, or serological procedures. All clinical labora- 
tory directors shall keep the department advised of current changes in 
employment of such technical personnel giving employment and/or sep- 
aration dates of personnel. 

Article 5. Issuance of License 



§ 1050. Clinical Laboratory Standards. 

(a) All licensed cHnical laboratories shall be conducted, maintained, 
and operated without injury to the public health and shall maintain re- 
cords, equipment, and facilities which are adequate and appropriate for 
the services rendered and demonstrate satisfactory performance in a pro- 
ficiency program approved by the department. 

(b) Proficiency Testing. 

(1) The laboratory must participate in a state approved proficiency 
testing program and demonstrate satisfactory performance in all of the 
laboratory speciaUies that include tests performed in the laboratory. Pro- 
ficiency shall be tested in the following specialties: microbiology, serol- 
ogy, clinical chemistry, hematology, and immunohematology. 

(2) The participating laboratory must test applicable materials each 
time they are distributed by the approved proficiency testing service ac- 
cording to a schedule approved by the department. 

(3) Those procedures performed by the laboratory for which test mate- 
rials are provided by the approved proficiency testing service and which 
have been designated by the department as a requirement for measuring 
test performance, must be proficiency tested by the participating labora- 
tory each time test materials are received. 

(4) The pardcipafing laboratory must authorize the approved profi- 
ciency testing service to report proficiency test results to the department. 

(5) The participating laboratory must test applicable materials only in 
the laboratory to which the license and the proficiency testing require- 
ment applies using personnel and equipment used in that facility in pro- 
viding services. 

(6) A laboratory may be required to discontinue providing a service in 
a procedure or category of procedures if: 



Page 22.1 



Register 2007, No. 26; 6-29-2007 



§1050 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(A) For three consecutive quarters the laboratory fails to report on test 
materials received for procedures for which the laboratory is required to 
be proficiency tested, or 

(B) For three consecutive quarters the laboratory demonstrates unsat- 
isfactory performance in a procedure or category of procedures. A deter- 
mination of satisfactory performance for a procedure shall be based upon 
results being within acceptable limits established by the proficiency test- 
ing service for that procedure and approved by the department. A deter- 
mination of satisfactory performance for a category of procedures shall 
be based upon an average of performance within the category over four 
consecutive quarters. 

(7) A laboratory whose services have been disapproved because of un- 
satisfactory performance may apply to the department for reapproval to 
provide these services after demonstrating satisfactory performance dur- 
ing the two consecutive quarters or testing periods immediately prior to 
requesting reapproval. 

(c) Direction. The person or persons directing a licensed clinical labo- 
ratory shall assume the following responsibilities: 

( 1 ) Determine what laboratory procedures will be performed, the tech- 
niques that will be followed, and the equipment and reagents that will be 
used. 

(2) Determine the scope and nature of procedures to control the reli- 
ability of test performance and personally monitor these control pro- 
grams. 

(3) Regularly assess the activities of the laboratory by personal obser- 
vation, evaluation, and review of reports of laboratory findings. 

(4) Establish qualification criteria of laboratory personnel. 

(5) Determine the format of laboratory report forms and decide what 
information is to be contained on these report forms. 

(6) Regularly consult with supervisors and other staff members. 

(7) Confer with those served by the laboratory on matters that relate 
to test performance and determine the nature and scope of technical and 
administrative information to be released by the laboratory staff. 

(8) Be available daily in any laboratory performing cytology and serve 
as director of no more than three (3) laboratories. 

(9) Cause a licensed physician or dentist, quahfied in cytopathology, 
to personally examine and report findings on abnormal or questionable 
gynecologic and all non-gynecologic specimens. 

(d) Facilities. The laboratory must pro\ ide for and assure that: 

(1) There is adequate space including working surface to conduct and 
control the performance of all test procedures performed in the laborato- 
ry. 

(2) There is adequate area for safe storage and use of equipment and 
supplies. 

(3) All areas are well lighted and properly ventilated. 

(4) Fume hoods and biological safety cabinets, properly installed and 
regulated, are used if required for safe performance of tests or for safe 
preparation of materials. 

(5) Instructions to be followed in case of fire and other emergencies 
are posted in a conspicuous place. 

(e) Equipment and Test Materials. 

( 1 ) The laboratory must provide for and assure that equipment, instru- 
ments, glassware, and reagents are maintained in proper working order 
by periodic inspection, testing, or calibration in a manner acceptable to 
the department. 

(2) All reagents and stains shall be dated at the time of preparation and 
initialed by the person making the reagents or stains, or the date received 
and date opened if commercially prepared reagents or stains are used. All 
reagents and stains shall be labeled to indicate identity, and titer, strength, 
or concentration. Recommended storage temperature and expiration 
date, and other pertinent information necessary for quaUty control must 
be on the label. 

(f) Records. 

(1) Retention of Records: The laboratory must maintain for a period 
of at least two years documentation of the following: 



(A) Records of specimens received and tested, including identification 
of the patient, name of the submitter, dates of receipt and report, type of 
test performed, and test results. 

(B) Records of inspection, validation, calibration, repair, and replace- 
ment to insure proper maintenance and operation of equipment and prop- 
er reactivity of test materials. 

(C) Manuals, card files, or flow charts for each procedure performed 
in the laboratory which include: 

1 . Name of procedure. 

2. Source or reference for the test method. 

3. Date the procedure was last reviewed or modified by the director or 
supervisor. 

4. Current specific instructions for test performance. 

5. The standards and controls required. 

6. Instructions for collecting and handling specimens to insure test re- 
liability. 

(D) Records of quality control procedures in use in the various techni- 
cal areas of the laboratory, including results on standards and reference 
materials and action limits when appropriate. 

(E) Additional requirements for cytology. The laboratory shall retain 
all cytology slides and cell blocks for a minimum of five (5) years and 
all cytology reports for a minimum of ten (10) years. 

(2) Cytology Specimen Documents. The laboratory shall maintain cy- 
tology records indicating the daily accession of specimens, each of which 
is numbered, and an appropriate cross-filing system according to pa- 
tient's name. 

(A) Requests shall contain at least the following information: 

1 . The laboratory accession number when assigned by the laboratory. 

2. The name of the person from whom the specimen was taken. 

3. The name of the licensed physician or other authorized person or 
clinical laboratory who submitted the specimen. 

4. Minimum information provided shall include: source of specimen 
(anatomic site), age of patient, previous therapy (endocrine, surgical, ra- 
diation, birth control, etc.), gynecologic history on cervical-vaginal 
specimens, including date and normalcy of patient's last menstrual peri- 
od, duration of patient's current pregnancy, if any, and patient's meno- 
pausal status or essential history on non-gynecologic specimen. 

5. The date the specimen was collected. 

(B) Reports shall contain at least the following information: 

1 . The dates the specimen was collected, received in the laboratory and 
reported by the laboratory; and the accession number. 

2. The result of the laboratory examination. 

(3) Cytology Laboratory Records. 

(A) The laboratory director shall be responsible for the final laboratory 
report and shall sign all abnormal and all non-gynecological reports. 
Each report, or a laboratory copy, shall be signed or initialed by the cyto- 
pathologist and/or cytotechnologist who examined the preparation and 
evaluated the final report. The names of all persons who examined the 
specimen and their evaluation, if inconsistent with the final report, shall 
be indicated on the laboratory work sheet or report copy. 

(B) Duplicate copies of laboratory reports are filed in a manner which 
permits ready identification and accessibility. 

(C) Laboratories shall utilize reporting systems that are as explicit as 
is cytologically feasible and must include acceptable morphologic termi- 
nology. 

(D) If a specimen is judged by the laboratory director or cytotechnolo- 
gist to be suboptimal, an accompanying statement shall indicate the rea- 
son, e.g., samples of sparse cellularity, poor preservation, or exhibiting 
other factors interfering with the laboratory evaluation, such as, exces- 
sive blood, inflammatory cells, etc. 

(g) Quality Control. 

(1) The laboratory must conduct, maintain, and operate programs for 
controlling the quality of test performance in a maimer acceptable to the 
department. 

(2) Additional Cytology. 



Page 22.2 



Register 2007, No. 26; 6-29-2007 



Title 17 



State Department of Health Services 



§ 1053.5 



(A) Specimen Identification. All smears and other specimens shall be 
labelled for patient identification and appropriately prepared by the sub- 
mitter. 

(B) Specimen Preparation. 

1. The laboratory shall use the Papanicolaou staining technique or its 
equivalent as determined by the laboratory director. 

2. Staining quality of cytologic specimens shall be checked at least 
once daily, with suboptimal results corrected immediately. 

3. Gynecologic specimens shall be processed totally separately from 
non-gynecologic specimens. 

(C) Microscopy. 

1 . Each specimen shall be evaluated to determine whether the material 
is satisfactory and consistent with the patient source. For satisfactory 
specimens, a cytologic evaluation shall be rendered according to the re- 
porting system, as outlined in Section 1 050(0(3 )(C). 

2. The laboratory shall have a sufficient number of certified cytotech- 
nologists to handle, under general supervision, the volume and diversity 
of tests performed requiring the exercise of independent judgment. No 
cytotechnologist shall be required to examine more than 75 one-shde gy- 
necologic cases or 50 two-slide gynecologic cases per day; not including 
aspiration cytology specimens, cell block specimens, and other not nor- 
mally examined by a cytotechnologist. Work load ratios for cytotechnol- 
ogists who also prepare and stain slides shall be based on time spent in 
examining cytologic preparations. 

3. The director or a supervising cytotechnologist shall examine (to 
verify proper staining and correct interpretation) at least ten (10) percent 
of all gynecologic smears previously examined and classified as not ab- 
normal or questionable, including smears initially examined by a super- 
vising cytotechnologist. 

(3) Clinical Correlation. The laboratory shall maintain records for a 
minimum of 10 years of histologic or clinical confirmation of cytologic 
findings on abnormal cases and false negative and false positive results 
for each category of specimens, when such results are made available to 
them. 

(h) Clinical Laboratory Test Results. Clinical laboratory test results 
shall not be reported from the laboratory until these results have been crit- 
ically reviewed and verified for accuracy, reliability, and validity by a h- 
censed physician and surgeon or a person, other than a trainee, duly li- 
censed under Chapter 3, Division 2, Business and Professions Code 
(commencing with Section 1200). 

NOTE; Authority cited: Sections 1224 and 1245, Business and Professions Code. 
Reference: Sections 1220, 1224 and 1245, Business and Professions Code. 

History 

1. New subsection (h) filed 2-17-77; effective thirtieth day thereafter (Register 
77, No. 8). For prior history, see Register 76, No. 51. 

2. Amendment of subsections (c), (f)(2)(A) and (B), (f)(3)(A), (g)(2)(A) and (B)3, 
(g)(2)(C)2. (g)(3) filed 1 0-1 3-78; effective thirtieth day thereafter (Register 78, 
No. 41). 



§ 1 051 . Proficiency Testing Services. 

A service may be approved by the department for proficiency testing 
laboratories providing the service: 

(a) Makes available to each participating laboratory 

( 1 ) Materials not less than four times during each calendar year for 
testing those procedures which have been designated by the department 
for evaluation, 

(2) Acceptable forms for reporting results of proficiency testing, 

(3) An evaluation of test results reported by the participating laborato- 
ry showing acceptable results based on a reference system approved by 
the department, and 

(4) A summary of results reported by all participating laboratories pre- 
pared at least annually. 

(b) Provides the department with an adequate description of accept- 
able procedures for 

( 1 ) The preparation and distribution of test materials, 

(2) The determination of limits of acceptable test results, and 



(3) The reporting of results of performance to the laboratories sub- 
scribing to the service. 

(c) Establishes and maintains an adequate reference system for each 
procedure evaluated. The names and addresses of all laboratories used as 
reference or referee laboratories by the service must be provided to and 
approved by the department. 

(d) Maintains records of proficiency testing including reports for par- 
ticipating laboratories for a period of not less than five years, such records 
being available to the department for reference upon request. These re- 
cords must include: 

( 1 ) The names and addresses of laboratories subscribing to the service. 

(2) The test procedures evaluated, 

(3) The results of performance reported by each laboratory, and 

(4) The results or range of results which were considered acceptable 
performance by the service. 

(e) Makes application for approval on forms provided by the depart- 
ment. 

History 

1. New section filed 12-28-71; effective thirtieth day thereafter (Register 72, 
No. 1). 

§ 1052. Satisfactory Performance in Proficiency Testing. 

The standards for satisfactory performance for laboratories operating 
in accordance with Subsections (b) and (g), Sections 1241, Division 2. 
Chapter 3, Business and Professions Code shall be those outlined in Sec- 
tion 1050(b) of this Title. 

NOTE: Authority cited: Sections 1224 and 1241.1, Business and Professions 
Code. 

History 

1 . New section filed 1 2-28-7 1 ; effective thirtieth day thereafter (Register 72, No. 
1). 

2. Amendment filed 2-17-77; effective thirtieth day thereafter (Register 77, 
No. 8). 

§1053. Definitions. 

NOTE: Authority cited: Sections 1220(a), 1224 and 1245, Business and Profes- 
sions Code. Reference: Sections 1206, 1209, 1220(a), 1224, 1245, 1265, 1282 and 
1285, Business and Professions Code. 

History 

1. New section filed 6-8-72; effective thirtieth day thereafter (Register 72, No. 
24). 

2. Amendment of subsection (e) and new subsections (f), (g) and (h) filed 
2-17-77; effective thirtieth day thereafter (Register 77, No. 8). 

3. New subsection (i) filed 10-13-78; effective thirtieth day thereafter (Register 
78, No. 41). 

4. Amendment of section and Note filed 12-27-94 as an emergency; operative 
12-27-94 (Register 94. No. 52). A Certificate of Compliance must be trans- 
mitted to OAL 4-26-95 or emergency language will be repealed by operation 
of law on the following day. 

5. Amendment of section and Notk refiled 5-5-95 as an emergency; operative 
5-5-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted 
to OAL by 9-4-95 or emergency language will be repealed by operation of law 
on the following day. 

6. Amendment refiled 9-15-95 as an emergency; operative 9-15-95 (Register 95. 
No. 37). A Certificate of Compliance must be transmitted to OAL by 1-15-96 
or emergency language will be repealed by operation of law on the following 
day. 

7. Reinstatement of section as it existed prior to 1 2-27-94 emergency amendment 
by operation of Government Code section 1 1346.1(f) (Register 96, No. 4). 

8. Renumbering and amendment of former section 1053 to section 1029 filed 
1-22-96 as an emergency; operative 1-22-96 (Register 96, No. 4). A Certifi- 
cate of Compliance must be transmitted to OAL by 5-2 1-96 or emergency lan- 
guage will be repealed by operation of law on the following day. 

9. Certificate of CompHance as to 1-22-96 order transmitted to OAL 5-2 1-96 and 
filed 6-18-96 (Register 96, No. 25). 



Article 5.2. Test Kits Approved for 
Over-the-Counter Sale to the Public by the 
United States Food and Drug Administration 

§1053.5. HIV Tests. 

The Department hereby adds to the tests that may be requested and re- 
ported pursuant to Business and Professions Code section 1246.5 any 



Page 22.3 



Register 97, No. 1 6; 4 - 1 8 - 97 



§ 1054.1 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



laboratory test or examination to identify HIV, a component of HIV, or 
antibodies or antigens to HIV when the test or examination has been ap- 
proved by the United States Food and Drug Administration for sale to the 
public without a prescription in the form of an over-the-counter test kit. 
NOTE: Authority cited: Sections 1224 and 1246.5, Business and Professions 
Code; and Section 100275, Health and Safety Code. Reference: Section 1246.5, 
Business and Professions Code; and Section 120775, Health and Safety Code. 

History 

1 . New article 5.2 (section 1 053.5) and section filed 1 1-6-96 as an emergency; op- 
erative 11-6-96 (Register 96, No. 45). A Certificate of Compliance must be 
transmitted to OAL by 3-5-97 or emergency language will be repealed by oper- 
ation of law on the following day. 

2. Certificate of Compliance as to 1 1-6-96 order transmitted to OAL 3-4-97 and 
filed 4-15-97 (Register 97, No. 16). 



Article 5.3. Blood Electrolyte Analysis by 
Respiratory Care Practitioners 

§ 1 054.1 . Conditions for Performance. 

(a) A Respiratory Care Practitioner may engage in clinical laboratory 
practice by performing a blood electrolyte analysis when all of the fol- 
lowing conditions are met: 

( 1 ) The blood electrolyte analysis is performed on an instrument which 
is designed to perform both blood gas analysis and blood electrolyte anal- 
ysis simultaneously or concurrently and from the same blood specimen; 

(2) The blood electrolyte analysis is performed in a licensed laboratory 
that: 

(A) is within a licensed surgical clinic or a licensed general acute care 
hospital; 

(B) has a CLIA certificate to perform blood gas analysis and blood 
electrolyte analysis; and 

(C) has established and maintains protocols for the performance and 
reporting of blood gas analysis and blood electrolyte analysis simulta- 
neously or concurrently from the same blood specimen by Respiratory 
Care Practitioners; 

(3) The blood electrolyte analysis is performed: 

(A) under the overall operation and administration of the laboratory 
director, as required in Section 1029 of the Business and Professions 
Code; and 

(B) in conformity with the protocols required in (2)(C), above; and 

(C) in conformity with the manufacturer's instructions. 

(4) The Respiratory Care Practitioner: 

(A) has been trained in accordance with Section 1054.2; and, 

(B) performs and reports simultaneous or concurrent blood gas analy- 
sis and blood electrolyte analysis in compliance with the requirements in 
(3), above; and 

(C) meets CLIA testing personnel qualifications for the type and com- 
plexity of tests being performed. 

NOTE: Authority cited: Secfion 1224, Business and Professions Code. Reference: 
Sections 1206, 1209, 1220, 1265, 1282 and 1285, Business and Professions Code. 

History 

1. New Article 5.3 (sections 1054.1 - 1054.2) and section filed 12-27-94 as an 
emergency; operative 12-27-94 (Register 94, No. 52). A Certificate of Com- 
pliance must be transmitted to OAL 4-26-95 or emergency language will be re- 
pealed by operation of law on the following day. 

2. New article 5.3 (sections 1054. 1-1054.2) and section refiled 5-5-95 as an emer- 
gency; operative 5-5-95 (Register 95, No. 18). A Certificate of Compliance 
must be transmitted to OAL by 9^1-95 or emergency language will be repealed 
by operation of law on the following day. 

3. New article 5.3 and section refiled 9-15-95 as an emergency; operative 
9-15-95 (Register95, No. 37). A Certificate of CompUance must be transmitted 
to OAL by 1-1 5-96 or emergency language will be repealed by operation of law 
on the following day. 

4. Repealed by operation of Government Code section 11346.1(g) (Register 96, 

No. 4). 



5. New section filed 1-22-96 as an emergency; operative 1-22-96 (Register 96, 
No. 4). A Certificate of Compliance must be transmitted to OAL by 5-21-96 
or emergency language will be repealed by operation of law on the following 
day. 

6. Editorial correction of subsection {a)(2) (Register 96, No. 25). 

7. Certificate of Compliance as to 1-22-96 order including amendment of Noth 
transmitted to OAL 5-21-96 and filed 6-18-96 (Register 96, No. 25). 

§1054.2. Training. 

(a) Prior to perforining a blood electrolyte analysis, a Respiratory Care 
Practitioner shall have completed the following training: 

( 1 ) instruction by the laboratory director, or by a person who qualifies 
as a technical consultant or a technical supervisor under CLIA, depend- 
ing on the type and complexity of the tests being performed, in: 

(A) the operation of each instrument to be used for simultaneous or 
concurrent blood gas analysis and blood electrolyte analysis by the Re- 
spiratory Care Practitioner, including the following: 

1 . Equipment maintenance and calibration; 

2. Method performance including the normal ranges and critical val- 
ues for each test protocol; 

3. Quality Control and Assurance requirements including remedial ac- 
tion and reagent and specimen handling and integrity; and, 

4. Clinical significance of test results and clinical applications for si- 
multaneous or concurrent blood gas analysis and blood electrolyte analy- 
sis. 

NOTE: Authority cited: Section 1224, Business and Professions Code. Reference: 
Sections 1209, 1220 and 1265, Business and Professions Code. 

History 

1 . New section filed 12-27-94 as an emergency: operative 12-27-94 (Register 94, 
No. 52). A Certificate of Compliance must be transmitted to OAL 4-26-95 or 
emergency language will be repealed by operation of law on the following day. 

2. New section refiled 5-5-95 as an emergency; operative 5-5-95 (Register 95, 
No. 18). A Certificate of Compliance must be transmitted to OAL by 9-4-95 
or emergency language will be repealed by operation of law on the following 
day. 

3. New section refiled 9-15-95 as an emergency; operative 9-15-95 (Register 
95, No. 37). A Certificate of Compliance must be transmitted to OAL by 
1-15-96 or emergency language will be repealed by operation of law on the fol- 
lowing day. 

4. Repealed by operation of Government Code section 1 1346.1(g) (Register 96, 
No. 4). 

5. New secfion filed 1-22-96 as an emergency; operafive 1-22-96 (Register 96, 
No. 4). A Certificate of Compliance must be transmitted to OAL by 5-21-96 
or emergency language will be repealed by operation of law on the following 
day. 

6. Certificate of Compliance as to 1-22-96 order including amendment of NOTE 
transmitted to OAL 5-21-96 and filed 6-18-96 (Register 96, No. 25). 

Article 5.5. Use of Point-of-Care 

Laboratory Testing Devices by Registered 

Nurses 

§ 1 054.5. Conditions for Performance. 

NOTE: Authority cited: Sections 1220(a) and 1224, Business and Professions 
Code. Reference: Secfions 1206, 1209, 1220(a), 1265, 1282 and 1285, Business 
and Professions Code. 

History 

1. New Article 5.5 (sections 1054.5 - 1054.6) and secfion filed 12-27-94 as an 
emergency; operative 12-27-94 (Register 94, No. 52). A Certificate of Com- 
pliance must be transmitted to OAL 4-26-95 or emergency language will be re- 
pealed by operation of law on the following day. 

2. New article 5.5 (secdons 1054.5-1 054.6) and secfion refiled 5-5-95 as an emer- 
gency; operafive 5-5-95 (Register 95, No. 18). A Certificate of Compliance 
must be transmitted to OAL by 9-4-95 or emergency language will be repealed 
by operation of law on the following day. 

3. New article 5.5 and secfion refiled 9-15-95 as an emergency; operafive 
9-1 5-95 (Register 95, No. 37). A Certificate of Compliance must be transmitted 
to OAL by 1-15-96 or emergency language will be repealed by operation of law 
on the following day. 

4. Repealed by operafion of Government Code secfion 11346.1(g) (Register 96, 
No. 4). 



Page 22.4 



Register 97, No. 16; 4-18-97 



Title 17 



State Department of Health Services 



§1057 



Article 5.6. Moderately Complex Laboratory 

Testing by Licensed Psychiatric 

Technicians, Licensed Vocational Nurses, 

Licensed Midwives, Certified Nurse 

Assistants, and Certified Home Health Aides 



§ 1054.6. Testing Authority for Licensed Psychiatric 
Technicians, Licensed Vocational Nurses, 
Licensed IVIidwives, Certified Nurse Assistants, 
and Certified Home Health Aides. 

NOTH: Authority cited: Section 1224 Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1 206.5, and 1209, Business 
and Professions Code. 

History 

1 . New section filed 1 2-27-94 as an emergency ; operati ve 1 2-27-94 ( Register 94, 
No. 52). A Ceilificate of Compliance must be transmitted to OAL 4-26-95 or 
emergency language will be repealed by operation of law on the following day. 

2. New section refiled 5-5-95 as an emergency; operative 5-5-95 (Register 95, 
No. 18). A Certificate of Compliance must be transmitted to OAL by 9-4-95 
or emergency language will be repealed by operation of law on the following 
day. 

3. New section refiled 9-15-95 as an emergency; operative 9-15-95 (Register 
95, No. 37). A Certificate of Compliance must be transmitted to OAL by 
I-l 5-96 or emergency language will be repealed by operation of law on the fol- 
lowing day. 

4. Repealed by operation of Government Code secfion 11346.1(g) (Register 96, 

No. 4). 

5. New article 5.6 (sections 1054.6-1054.7), section heading, section, and Note 
filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, No. 22). A 
Certificate of Compliance must be transmitted to OAL by 9-25-96 or emergen- 
cy language will be repealed by operation of law on the following day. 

6. New article 5.6 (sections 1054.6-1054.7) and section refiled 10-7-96 as an 
emergency; operative 10-7-96 (Register 96. No. 41). A Certificate of Com- 
pliance must be transmitted to OAL by 2-4-97 or emergency language will be 
repealed by operafion of law on the following day. 

7. Certificate of Compliance as to 10-7-96 order, including repealer of secfion, 
transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12). 

§ 1054.7. Preceptor Program Requirements for Licensed 
Psychiatric Technicians, Licensed Vocational 
Nurses, Licensed Midwives, Certified 
Emergency Medical Technicians 11, 
Paramedics, Certified Nurse Assistants, and 
Certified Home Health Aides Performing 
Moderate Complexity Testing on Point-of-Care 
Laboratory Testing Devices. 
(a) Prior to the performance of any clinical laboratory test or examina- 
tion authorized in Business and Professions Code Section 1206.5(b)(ll), 
a licensed psychiatric technician, licensed vocational nurse, licensed 
midwife, certified emergency medical technician II, paramedic, certified 
nurse assistant or certified home health aide shall have been trained by 
a preceptor in: 

( 1 ) The operation of each instrument to be used by the licensed psy- 
chiatric technician, licensed vocation nurse, licensed midwife, certified 
emergency medical technician II, paramedic, certified nurse assistant or 
certified home health aide including: 

(A) Each instrument's requirements for maintenance and calibration 
which shall include training regarding all manufacturer's instructions; 

(B) Each instrument's performance criteria including the reference 
ranges, critical values for each test method, and actions to be taken for 
values outside the analytical range; and 

(C) Each instrument's quality control and quality assurance protocols, 
including remedial action and reagent and specimen handling and integ- 
rity; and, 

(2) The clinical significance of test results for each instrument and the 
clinical application for use of the instruments by licensed psychiatric 
technicians, licensed vocational nurses, licensed midwives, certified 



emergency medical technicians II, paramedics, certified nurse assistants 
or certified home health aides; and, 

(3) The common physiological conditions of patients that may impact 
specimen integrity and cause inaccurate test results; and 

(4) Principles of good laboratory practice including laboratory safety 
and universal precautions. 

(b) Prior to the utilization, for patient care, prognosis, monitoring, 
treatment, or disease prevention, of any clinical laboratory test or exami- 
nation performed by him or her, a licensed psychiatric technician. li- 
censed vocational nurse, licensed midwife, certified einergency medical 
technician II, paramedic, certified nurse assistant, certified home health 
aide shall have the following experience and shall have been determined 
to be coiTipetent to perform moderate complexity tests by the laboratory 
director or a person who qualifies as a technical consultant pursuant to 
Business and Professions Code Section 1209: 

( 1 ) He or she shall participate in a preceptor program until such time 
as he or she is able to perform clinical laboratory tests or examinations 
with results that are consistent with the preceptor's results 907f of the 
time over 20 separate testing events which taken together, cover the en- 
tire range of expected values for the instalment. 

(2) The experience requirement in subsection (b)(1) shall be met for 
each instrument to be used by the licensed psychiatric technician, li- 
censed vocaUonal nurse, licensed midwife, certified emergency medical 
technician II, paramedic, certified nurse assistant or certified home 
health aide. 

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section 
100275, Health and Safety Code. Reference: Sections 1206.5, 1209, and 1220, 
Business and Professions Code. 

History 

1. New secfion filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, 
No. 22). A Certificate of Compliance must be transmitted to OAL by 9-25-96 
or emergency language will be repealed by operation of law on the following 
day. 

2. New section refiled 1 0-7-96 as an emergency; operative 1 0-7-96 (Register 96, 
No. 41 ). A Certificate of Compliance must be transmitted to OAL by 2-4-97 
or emergency language will be repealed by operation of law on the following 
day. 

3. Certificate of Compliance as to 1 0-7-96 order, including amendment of .section 
heading and section, transmitted to OAL 2-3-97 and filed 3-19-97 (Register 
97, No. 12). 



Article 6. Laboratory Reports 

§1055. Reports. 

Any report of results issuing from a clinical laboratory operating under 
the provisions of Chapter 3, Division 2, Business and Professions Code 
shall show clearly the name of a director of said laboratory. 
Note: Authority cited: Sections 102 and 208. Health and Safety Code. Reference: 
Sections 1220, 1225, 1284 and 1285, Health and Safety Code. 

History 
1. New secfion filed 9-30-60; effecfive thirtieth day thereafter (Register 60. No. 

21). 



§ 1056. Prenatal and Neonatal Blood Typing. 

For purposes of compUance with Sections 29 1 and 304 of the Califor- 
nia Health and Safety Code, rhesus (Rh) blood typing (as defined in Title 
17, California Administrative Code, Chapter 2, Subchapter 1, Group 1, 
Secfion 1002, Number 3, [DeterminaUon of Rh type]) shall con.sist of D 
and if this is negafive, D" typing. 

NOTE: Addifional authority cited: Sections 290-293 and 304-305. Health and 
Safety Code. 

History 

1. New Sections 1056 and 1057 filed 3-16-70; effective thirtieth day thereafter 
(Register 70, No. 12). 

2. Amendment filed 2-2-7 1 ; effecfive thirtieth day thereafter ( Register 7 1 . No. 6 ). 

3. Editorial correction (Register 72, No. 31 ). 

§ 1057. Prenatal Blood Typing Reports. 

Licensed clinical laboratories or approved public health laboratories 
performing tests on pregnant women as required by Sections 290 and 29 1 



Page 22.4(a) 



Register 97, No. 12; 3-21-97 



§1060 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



of the California Health and Safety Code shall provide the requesting 
physician with a copy of the report to be stamped or imprinted as follows: 
"State law requires that the woman tested be informed as to the rhesus 
(Rh) typing test results." 

Every licensed physician and surgeon or other person engaged in the 
prenatal care of a pregnant woman, or attending such woman at time of 
delivery after receiving such report, shall be responsible for notifying the 
woman tested of the results of the test. 

History 

1 . Amendment filed 2-2-7 1 ; effective thirtieth day thereafter (Register 71, No. 6). 



Article 7. Cytotechnology 



§ 1060. Definitions: Cytotechnologist License. 

(a) The definitions in subsections (b) though (i) shall govern the inter- 
pretation of this article. 

(b) "Competency testing service or program" means an organization 
that has been approved by the Department pursuant to section 1270 of the 
California Business and Professions Code to administer a cytotechnolo- 
gy competency examination. 

(cj "Cytotechnologist competency examination" means an examina- 
tion which evaluates a person's entry level skills and abilities in cytotech- 
nology, including his or her understanding of: ( 1 ) the underlying scientif- 
ic principles, technical and procedural aspects of cytotechnology; (2) the 
identification of cellular changes in gynecological and non-gynecolog- 
ical specimens through both a written and visual component; (3) cytopre- 
paratory techniques; and (4) cytology laboratory operations; and which 
include the following subject areas in the following ratios: 48% to 52% 
female reproductive system (to include both the genital system and 
breast); 1 3% to 1 7% respiratory system; 9% to 1 2% male and female gen- 
itourinary systems; 6% to 10% alimentary system; and 13% to 17% body 
cavity fluids and other body sites. 

(d) "Entry Level Skills" means the following skills and abilities ex- 
pected at career entry: 

( 1 ) Knowledge and understanding of: 

(A) the underlying scientific principles as well as the technical and 
procedural aspects of the examination of cytology specimens; 

(B) the physiological, biochemical, microbiological, and genetic fac- 
tors which affect cell health and disease, and the importance of cytology 
laboratory examinations to medical care; 

(C) quality assurance sufficient to monitor and to implement quaUty 
control programs; 

(D) the introduction and implementation of new procedures and the 
evaluation of new instruments; 

(E) basic management theory and functions. 

(2) Technical skills so that the examinee is capable of: 

(A) performing examinations on cytology specimens; 

(B) exercising initiative and independent judgment in deaUng with the 
broad scope of procedural and technical j^roblems; 

(C) participating in, or being delegated, the responsibility for deci- 
sions involving quality control programs, or reagent purchases; 

(D) communicating technical or general information to medical, para- 
medical, or lay individuals; 

(E) participating in and developing responsibility for the establish- 
ment of technical and administrative procedures; 

(F) supervising technicians, aides, and clerical personnel, as directed; 
and, 

(G) providing instruction in the basic theory, technical skills, and 
application of cytology laboratory procedures. 

(e) "Examinee" means an individual who meets the following require- 
ments: 

( 1 ) Has a baccalaureate degree from a college or university accredited 
by the Western Association of Schools and Colleges or its equivalent 
with 20 semester hours (30 quarter hours) of biological science, 8 semes- 



ter hours (12 quarter hours) of chemistry and 3 semester hours (4 quarter 
hours) of mathematics; and 
(2) Has completed: 

(A) A 12-month cytotechnology program accredited by the Council 
on Accreditation of Allied Health Educational Program (CAAHEP) or its 
equivalent; or 

(B) Five years, of at least 40 hours a week, clinical laboratory experi- 
ence in cytopreparatory techniques, microscopic analysis and evaluation 
of the body systems within the last ten years. At least two of these years 
must be subsequent to the completion of the academic component and at 
least two years must be under the supervision of a licensed physician who 
is a pathologist certified or eligible for certification by the American 
Board of Pathology in Anatomic Pathology or has other qualifications 
acceptable to the competency testing service or program. 

(f) "Evidence of Satisfactory Performance" means (1 ) a copy of a doc- 
ument issued to an examinee after January 1, 1993 by a cytotechnology 
competency testing service or program indicating satisfactory perform- 
ance by the examinee on a cytotechnologist competency examination; or 
(2) a copy of a document issued to an individual by the American Society 
of Clinical Pathologists (ASCP) Board of Registry (BOR) indicating sat- 
isfactory performance by the individual on an ASCP Cytotechnology Ex- 
amination taken prior to the approval of a competency testing service or 
program under the provisions of this article. 

(g) "Satisfactory performance" means ( 1 ) receipt of a passing score on 
a cytotechnologist competency examination given after January 1 , 1 993; 
or (2) passage of an ASCP Cytotechnology Examination prior to the ap- 
proval of a competency testing service or program under the provisions 
of this article. 

(h) "Passing score" means a score determined by a cytotechnologist 
competency testing service or program utilizing the criteria approved by 
the Department pursuant to section 1062. 

(i) "Owner(s)" means any person who is a sole proprietor, or holds a 
partnership interest in, or who is an officer, director, or 5% (five percent) 
or more shareholder in a corporation which owns an organization that is 
applying for approval as a cytotechnologist testing service or program. 

Note: Authority cited: Sections 1224 and 1270, Business and Professions Code. 
Reference: Section 1270, Business and Professions Code. 

History 

1 . New article 7 and section filed 1 1-1 8-93 as an emergency; operative 1 1-1 8-93 
(Register 93, No. 47). A Certificate of Compliance must be transmitted to OAL 
by 3-1 8-94 or emergency language will be repealed by operation of law on the 
following day. 

2. Certificate of Compliance as to 11-18-93 order transmitted with amendment 
of subsections (e)(2)(A) and (f) to OAL 3-18-94 and filed 4-29-94 (Register 
94, No. 17). 

§ 1 061 . Cytotechnology Licensure. 

(a) A cytotechnologist Hcense shall be issued to an individual who sub- 
mits the following to the Department: 

(1 ) A verified and complete application as described in subsection (b); 

(2) Evidence of satisfactory performance; 

(3) The application fee required under Business and Professions Code 
Section 1300 and Health and Safety Code Section 116. 

(b) A complete application for a cytotechnologist license shall include 
the following verified information on a form. Application for Cytotech- 
nologist License (LAB 124, Rev. 1 1/93), provided by the Department: 

(1 ) Name, address, social security number (optional), and ASCP regis- 
tration number, if any, of the applicant; and 

(2) The applicant's education, training and experience in gynecologi- 
cal and non-gynecological cytology including: 

(A) An official copy of any and all college credits including a state- 
ment of any degrees conferred; and 

(B) Documentation of each of the following, if completed or obtained 
by the applicant: 

1. The completion of a 12 month training program approved by 
CAAHEP or its equvalent, or 

2. The completion of five years of full-time, of at least 40 hours a 
week, clinical laboratory experience in cytology; 



Page 22.4(b) 



Register 97, No. 12; 3-21-97 



Title 17 



State Department of Health Services 



§1061 



3. ASCP registration certificate; 

4. Licensure by tlie Department under Business and Professions Code 
section 1270 subsection (c) or subsection (d); and 

(3) The name and address of the applicant's current laboratory em- 
ployer(s), and the number of hours employed (by each) and the time de- 
voted, and volume of types of specimens examined at each location. 

(c) Within 30 calendar days of receipt of an application for a cytotech- 
nologist license, the Department shall inform the applicant in writing that 
the application is either complete and accepted for filing or that it is in- 
complete and what specific information is required before the application 
may be accepted for filing. 



(d) Within 90 calendar days from the date the Department receives the 
information and documentation required in subdivision (a), it shall in- 
form the applicant in writing whether a cytotechnologist license shall be 
issued or denied. If a license is denied, the Department shall indicate the 
reasons therefor. 

(e) The Department's time periods for processing an application for 
cytotechnologist license, from receipt of the initial application to the final 
decision regarding the license, are as follows: 

( 1 ) The median time for processing is 240 calendar days. 

(2) The minimum time for processing is 120 calendar days. 



[The next page is 22.5. 



Page 22.4(c) 



Register 97, No. 12; 3-21-97 



Title 17 



State Department of Health Services 



§1065 



(3) The maximum time for processing is 360 calendar days. 

(f) Eacli licensed cytotechnologist shall notify the Department within 
30 calendar days of any and all changes in his or her employment, includ- 
ing any changes in the name and address of his or her employer(s), the 
hours employed by each, and the information specified in subsection 
(b)(3) above. 

NOTl-:: Authority cited: Sections 1224, 1270 and 1271(f), Business and Profes- 
sions Code. Reference; Sections 1270, 1271 and 1300, Business and Professions 
Code; Section 15376, Government Code; and Section 116, Health and Safety 
Code. 

History 

1 . New section filed 1 1-18-93 as an emergency; operative 1 1-18-93 (Register93. 
No. 47). A Certificate of Compliance must be transmitted to OAL by 3-18-94 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 1 1-18-93 order transmitted with amendment 
of subsection (b)(2)(B) 1 to OAL 3-18-94 and filed 4-29-94 (Register 94, No. 
17). 

§ 1 062. Cytotechnologist Competency Testing Services Or 
Programs. 

(a) Any organization seeking approval by the Department as a cyto- 
technologist competency testing service or program shall submit an 
application to the Department which shall include documentation of the 
following: 

(1) The organization's name, address, and owner(s); 

(2) The organization's mechanism for assuring that each individual for 
whom a cytotechnologist competency testing examination is adminis- 
tered meets the criteria as an examinee; 

(3) The organization's mechanism for assuring that each cytotechnol- 
ogist competency examination administered by the organization shall 
test each examinee on his or her entry level skills and understanding of: 

(A) The underlying scientific principles and the technical and proce- 
dural aspects of cytology; 

(B) The identification of cellular changes in gynecologic and non-gy- 
necologic specimens through both a written and visual component; 

(C) Cytopreparatory techniques; and 

(D) Cytology laboratory operations, and that each test shall include the 
following subject areas in the following ratios: 487c to 52% female repro- 
ductive system (to include both genital system and breast); 1 3%-l 7% re- 
spiratory system; 9%-12% male and/or female genitourinary system; 
6%-10% alimentary system; and 13%-17% body cavity fluids and other 
body sites; 

(4) The organization's mechanism for determining the validity and 
passing score for each cytotechnologist competency examination admin- 
istered by the organization in order that there is a consistency between 
and among all testing events as to entry level skills that must be demon- 
strated in order for an examinee to pass the examination; and, 

(5) The organization' s mechanism for assuring the security of each cy- 
totechnologist competency examination administered by it. 

(b) Upon receipt of the above, and the determination by the Depart- 
ment that the documentation provides assurances of the following, the 
Department shall approve the organization as a cytotechnologist compe- 
tency testing service or program and shall issue an approval document 
indicating the terms of the organization's approval: 

(1) The organization shall only administer cytotechnologist compe- 
tency examinations to persons who qualify as an examinee; 

(2) Each cytotechnologist competency examination administered by 
the organization shall challenge each examinee on his or her entry level 
skills and understanding of the subjects, and shall contain the subject 
matter in the ratios identified in subsection (a) (3), above; 

(3) Each cytotechnologist competency examination administered by 
the organization shall be validly constructed and have a passing score 
that fosters a consistency between and among all testing events as to entry 
level skills that must be demonstrated in order for an examinee to pass 
the examination; and, 

(4) Each cytotechnologist competency examination shall be adminis- 
tered in a secure fashion. 



(c) Within 15 days of receipt of an application by an organization for 
approval as a cytotechnologist competency testing service, the Depart- 
ment shall inform the organization in writing that the application is com- 
plete and accepted for review or deficient and what specific information 
or documentation is required to complete the application. 

(d) Within 30 calendar days from the date of filing of a completed 
application, the Department shall inform the applicant organization in 
writing whether the organization has been approved as a cytotechnolo- 
gist competency testing service or program. 

(e) The Department's time periods for processing an application for 
approval as a cytotechnologist competency testing service or program, 
from the receipt of the initial application to the final decision regarding 
the approval, are as follows: 

(1) The median time for processing is 90 calendar days. 

(2) The minimum time for processing is 45 calendar days. 

(3) The maximum time for processing is 135 calendar days. 

(f) Cytotechnologist competency testing services or programs shall is- 
sue a document to each examinee who obtains a passing score on each 
cytotechnologist competency examination administered by the service 
or program. 

(g) Cytotechnologist competency testing services or programs shall 
maintain, for a minimum of five years, and .shall make available to the 
Department, records showing the validation, content, passing score, date 
and place of each competency testing examinafion administered by it, 
and a record of each examinee tested. 

(h) A cytotechnologist competency testing service or program shall be 
subject to review by the Department to determine adherence to the re- 
quirements of this article and its approval. Failure of a cytotechnologist 
competency tesdng service or program to meet the requirements of this 
article or its terms of approval shall constitute good cause for revocation 
of approval by the Department. 

NOTE: Authority cited; Sections 1224 and 1270, Business and Professions Code. 
Reference; Section 1270, Business and Professions Code; and Section 15376, 
Government Code. 

History 

1. New section filed 1 1-18-93 as an emergency; operative 1 1-18-93 (Register 93, 
No. 47). A Certificate of Compliance must be transmitted to OAL by 3-1 8-94 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 1 1-18-93 order transmitted with amendment 
of subsection (a)(3)(D) to OAL 3-18-94 and filed 4-29-94 (Register 94, No. 
17). 



Article 8. Enforcement 

§1065. Imposition of Sanctions. 

(a) The department may impose, as applicable, one or more of the fol- 
lowing sanctions on a clinical laboratory, a public health laboratory or a 
provider of service: 

(1) Principal sanctions. 

(2) Intermediate sanctions. 

(3) Altemafive sanctions. 

(4) Automafic suspension of a license or registrafion based on federal 
exclusion from the Medicare or Medicaid program or revocation of 
CLIA certificate. 

(5) State-initiated exclusions from the Medicaid and Medi-Cal pro- 
grams. 

(6) Exclusion from ownership or operation for two years following li- 
cense or registration revocation. 

(7) Civil suit to enjoin statutory or regulatory violations. 

(8) Criminal sanctions for unlawful activity. 

(9) Automatic revocation of license/registration or other approval 
based on intentional referral of proficiency testing samples for analysis. 

(10) Suspension of Medi-Cal and Medicaid payments for failure to 
permit an inspection. 

(b) The department's decision to impose sanctions shall be based on 
one or more of the following: 



Page 22.5 



Register 98, No. 7; 2-13-98 



§ 1065.5 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



( 1 ) Deficiencies found by the department or its agents in tlie conduct 
of inspections or through review of materials submitted by a laboratory 
(e.g., personnel qualifications). 

(2) Unsuccessful participation in proficiency testing. 

(c) The department shall base its choice of sanction or sanctions to im- 
pose on consideration of one or more factors that include, but are not lim- 
ited to. the following, as assessed by the department or its agents: 

(1) Whether the deficiencies pose immediate jeopardy. 

(2) The nature, incidence, severity, and duration of the deficiencies or 
noncompliance. 

(3) Whether the same condition level deficiencies have been identified 
repeatedly. 

(4) The accuracy and extent of laboratory records (e.g.. of remedial ac- 
tion) in regard to the noncompliance, and their availability to the depart- 
ment, to its agents, or to the United States Health Care Financing Admin- 
istration and its agents. 

(5) The relationship of one deficiency (ir group of deficiencies to other 
deficiencies. 

(6) The overall compliance history of the laboratory. 

(7) The corrective and long-term compliance outcomes that the de- 
partment hopes to achieve through application of the sanction. 

(8) Whether the laboratory has made any progress toward improve- 
ment following a reasonable opportunity to correct deficiencies. 

(d) The department shall impose a separate sanction for each condition 
level deficiency or a single sanction for all condition level deficiencies 
that are interrelated and subject to correction by a single course of action. 

NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Healthand Safety Code; Stats. 1995,c.510, Section 1; and Section 14105, 
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section 
101 160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 
1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326, Business 
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government 
Code; 42 USC Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 
United States Code, Section 1 395w-2 [Section 1 846 of the federal Social Security 
Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the 
federal Social Security Act]; 42 United States Code, Section 1396a{a)(30) [Sec- 
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) 
[Section 1 902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sec- 
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; 
and 42 CFR Section 493.1840. 

History 

1. New article 8 (sections 1065-1067.15) and section filed 8-28-97 as an emer- 
gency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance 
must be transmitted to OAL by 1 2-26-97 or emergency language will be re- 
pealed by operation of law on the following day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§1065.5. Principal Sanctions. 

(a) The department may impose on a clinical laboratory the principal 
sanctions of denial, revocation or suspension of a registration or license 
issued under chapter 3 of division 2 of the liusiness and Professions Code 
whenever it determines that any of the grounds identified in Business and 
Professions Code section 1320 exist and it has complied with the require- 
ments of Business and Professions Code sections 1267 and 1322. Aclini- 
cal laboratory that has had a Statement ol Issues or an Accusation filed 
against it for the denial, revocation or suspension of its license or registra- 
tion may defend itself, its owner(s) and director(s) by filing a notice of 
defense in accordance with section 1 150() of the Government Code. A 
clinical laboratory that is dissatisfied with a final decision regarding a de- 
nial, revocation or suspension may seek judicial review in accordance 
with section 11523 of the Government Code. 

(b) The department may impose on a public health laboratory the prin- 
cipal sanctions of denial, revocation or suspension of the approval to op- 
erate a public health laboratory granted under article 5 (commencing 
with section 101 150) of the Health and Safety Code whenever it deter- 
mines that the requirements identified in 17 CCR section 1078 are not be- 
ing met and it has complied with chapter 5 (commencing with section 
11 500) of part 1 of division 3 of title 2 of the Government Code. A public 
health laboratory that has had a Statement of Issues or an Accusation filed 



against it for the denial, revocation or suspension of its approval to oper- 
ate may defend itself by filing a notice of defense in accordance with sec- 
tion 1 1506 of the Government Code. A public health laboratory that is 
dissatisfied with a final decision regarding a denial, revocation or suspen- 
sion may seek judicial review in accordance with section 1 1523 of the 
Government Code. 

(c) The department may impose on a provider of service the principal 
sanction of suspension from further participation in, including reim- 
bursement from, the Medi-Cal and Medicaid programs whenever it de- 
termines that any of the grounds identified in Welfare and Institutions 
Code section 141 23 exist and it has complied with chapter 5 (commenc- 
ing with section 1 1500) of part 1 of division 3 of title 2 of the Government 
Code, except that hearings may be conducted by departmental hearing 
officers appointed by the director. A provider of service that has had an 
Accusation filed against it for its suspension from further participation 
in the Medi-Cal program may defend itself its owner(s) or director(s) by 
filing a notice of defense in accordance with section 1 1506 of the Gov- 
ernment Code. A provider of service that is dissatisfied with a final deci- 
sion regarding suspension from further participation in the Medi-Cal 
program may seek judicial review in accordance with section 1 1523 of 
the Government Code. 

NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; Stats. 1 995, c.5 10, Section 1; and Section 14105, 
Welfare and Institutions Code. Reference: Stats. 1995, c.5 10, Section 1; Section 
101160, Health and Safety Code; Sections 1265, 1267, 1280. 1281, 1282, 1283, 
1284, 1285, 1286, 1287, 1288.5. 1289, 1310, 1320. 1323, 1324and 1326,Business 
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government 
Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 
United States Code, Section 1395w-2 [Section 1846 of the federal Social Security 
Act] ; 42 United States Code, Section 1 396a(a)(9)(C) [Section 1 902(a)(9)(C) of the 
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec- 
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) 
[Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sec- 
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; 
and 42 CFR Section 493.1840. 

History 

1. New section filed 8-28-97 as an emergency; operafive 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsec- 
tion (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7). 



§ 1 065.1 0. Intermediate Sanctions. 

(a) The department may impose on a cUnical laboratory the intermedi- 
ate sanction of temporary suspension of a registration or license issued 
under chapter 3 of division 2 of the Business and Professions Code based 
on a departmental finding of immediate jeopardy or other grounds identi- 
fied in Business and Professions Code secfion 1323. The intermediate 
sanction becomes effective upon the serving of an Accusation. A clinical 
laboratory that has had an Accusation filed against it for temporary sus- 
pension of its license or registration may defend itself its owner(s) and 
director(s) by filing a notice of defense in accordance with section 1 323 
of the Business and Professions Code. Regardless of a notice of defense 
being filed, the temporary suspension remains in effect at least until the 
hearing is completed and the department has made a final determination 
on the merits. A clinical laboratory that is dissaUsfied with a final deter- 
mination on the merits may seek judicial review in accordance with sec- 
tion 1 1523 of the Government Code. 

(b) The department may impose on a public health laboratory the inter- 
mediate sanction of temporary suspension of the approval to operate a 
public health laboratory granted under article 5 (commencing with sec- 
tion 101 150) of the Health and Safety Code based on a departmental find- 
ing of immediate jeopardy. The intermediate sanction becomes effective 
upon the serving of an Accusation. A public health laboratory that has had 
an Accusation filed against it for temporary suspension of its approval 
may defend itself, its owner(s) and director(s) by filing a notice of defense 
in accordance with section 1 1506 of the Government Code. Regardless 
of a nodce of defense being filed, the temporary suspension remains in 
effect at least until the hearing is completed and the department 



Page 22.6 



Register 98, No. 7; 2-13-98 



Title 17 



State Department of Health Services 



§ 1065.30 



has made a final determination on the merits. A public health laboratory 
that is dissatisfied with a final determination on the merits may seek judi- 
cial review in accordance with section 1 1523 of the Government Code, 
(c) The department may impose on a provider of service the intermedi- 
ate sanction of temporary suspension from participation in, including re- 
imbursement from, the Medi-Cal and Medicaid programs based on a de- 
partmental finding of immediate jeopardy or condition level deficiencies 
and when in the opinion of the director of the department such action is 
necessary to protect the public welfare or the interests of the Medi-Cal 
program. The intermediate sanction becomes effective upon the serving 
of an Accusation. A provider of service that has had an Accusation filed 
against it for temporary suspension from participation in the Medi-Cal 
program may defend itself, its owner(s) and director(s) by filing a notice 
of defense in accordance with section 1 1506 of the Government Code. 
Regardless of a notice of defense being filed, the temporary suspension 
remains in effect at least until the hearing is completed and the depart- 
ment has made a final determination on the merits. A provider of service 
that is dissatisfied with a final determination on the merits may seek judi- 
cial review in accordance with section 1 1523 of the Government Code. 
NOTIi; Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; Stats. 1995,c.510, Section l;and Section 14105, 
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section 
1011 60, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282. 1283, 
1284, 1285, 1286. 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326, Business 
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government 
Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 
United States Code, Section 1 395 w-2 [Section 1 846 of the federal Social Security 
Act];42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the 
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec- 
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) 
[Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sec- 
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; 
and 42 CFR Section 493.1840. 

History 

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsec- 
tion (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7). 



§ 1 065.1 5. Alternative Sanctions. 

(a) The department may impose on a clinical laboratory one or more 
of the following alternative sanctions in lieu of or in addition to imposing 
a principal sanction: 

(1) Directed plans of correction, as set forth in section 1067. 

(2) Onsite monitoring, as set forth in section 1067.10. 

(3) Civil money penalties, as set forth in section 1067.5. 

(b) Prior to the imposition of an alternative sanction a clinical laborato- 
ry shall be given a Notice of Intent and an opportunity to respond. A clini- 
cal laboratory that is dissatisfied with the imposition of an alternative 
sanction may seek judicial review by filing a petition for writ of mandate 
in accordance with the provisions of the Code of Civil Procedure. 
Note: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; Stats. 1995, c.5 10, Section 1; and Section 14105, 
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section 
101 160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 
1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323. 1324and 1326, Business 
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government 
Code; 42 USC, Section 1395x(s) [Section 186I(s) of the Social Security Act]; 42 
United States Code, Section 1 395 w-2 [Section 1 846 of the federal Soci;il Security 
Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1 902(a)(9)(C) of the 
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec- 
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) 
[Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sec- 
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; 
and 42 CFH Section 493.1840. 

History 

1. New section filed 8-28-97 as an emergency; operadve 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 



2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24--97 
and filed 2-9-98 (Register 98. No. 7). 

§1065.20. Automatic Suspension. 

The department shall automatically suspend a clinical laboratory li- 
cense or registration based on federal exclusion from the Medicare or 
Medicaid program or revocation of CLIA certificate. A clinical laborato- 
ry that is dissatisfied with the imposition of an automaUc suspension may 
seek judicial review by filing a petition for writ of mandate in accordance 
with the provisions of the Code of Civil Procedure. 
NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Heahh and Safety Code; Stats. 1 995. c.5 10, Section 1; and Section 14105. 
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section 
101 160, Health and Safety Code; Sections 1265, 1267, 1280. 1281, 1282. 1283. 
1284, 1285, 1286, 1287. 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326. Business 
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government 
Code; 42 USC, Secfion 1395x(s) [Section 1861(s) of the Social Security Actj; 42 
United States Code, Secfion 1 395w-2 [Section 1846 of the federal Social Security 
Act]; 42 United States Code, Section I396a(a)(9)(Cj [Section 1902(a)(9)(C) of the 
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec- 
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) 
[Secfion 1902(p) of the Social Security Act); 42 CFR Section 1002.2; 42 CFR Sec- 
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; 
and 42 CFR Section 493.1840. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35 ). A Certificate of Compliance must be transmitted to OAL by 1 2-2(>-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1065.25. State-initiated Exclusions from Medicaid and 
IVIedi-Cal. 

The department may initiate exclusions from Medicaid and Medi-Cal 
when the grounds for taking a permissive exclusion under 42 CFR part 
1002 exist. The department shall initiate exclusions from Medicaid and 
Medi-Cal when the grounds for taking a mandatory exclusion under 42 
CFR part 1002 exist. Before imposing an exclusion, the department shall 
give a provider of service an opportunity to submit documents and writ- 
ten argument against the exclusion. A provider of service that is dissatis- 
fied with the imposition of an exclusion may seek judicial review by fil- 
ing a petition for writ of mandate in accordance with the provisions of the 
Code of Civil Procedure. 

NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; Stats. 1995, c.510. Section l;and Section 1410.5. 
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section 
101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 
1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326,Bu.siness 
and Professions Code; Sections 11503, 11504, 11506 and 11523, Govemment 
Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 
United States Code. Secfion 1 395w-2 [Section 1 846 of the federal Social Security 
Act]; 42 United States Code, Secfion 1396a(a)(9)(C) [Secfion 1902(a)(9)(C) of the 
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec- 
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) 
[Section 1 902(p) of the Social Security Act] ; 42 CFH Section 1 002.2; 42 CFR Sec- 
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; 
and 42 CFR Section 493.1840. 

History 

1. New secfion filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 1 2-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1065.30. Exclusion from Ownership or Operation. 

The department shall exclude for a period of two years following revo- 
caUon any person or entity from owning, operating, or directing a labora- 
tory, whenever the person or entity has been the owner, operator or labo- 
ratory director of a clinical laboratory that has had its clinical laboratory 
license or registration revoked. A person or entity that is dissatisfied with 
the imposition of an exclusion from owning or operating a clinical labo- 
ratory may seek judicial review by filing a petition for writ of mandate 
in accordance with the provisions of the Code of Civil Procedure. 
NOTE: Authority cited: Secfion 1224, Business and Professions Code; Section 
100275, Health and Safety Code; Stats. 1995, c.510. Section 1; and .Section 



Page 22.7 



Register 98, No. 7; 2-13-Q 



§ 1065.35 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



14103, Welfaie and Institutions Code. Reference: Stats. 1995, c.510. Section 1; 
Section 101 160, Health and Salety Code; Sections 1265. 1267, 1280, 1281, 1282, 

1283, 1284, 1285, 1286. 1287. 1288.5, 1289, 1310. 1320. 1323, 1324 and 1326, 
Business and Professions Code; Sections 1 1503, 1 1504, 1 1506 and 1 1523, Gov- 
ernment Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security 
Act]; 42 United States Code, Section 1 395w-2 [Section 1846 of the federal Social 
Security ActJ; 42 United States Code. Section 1396a(a)(9)(C) [Section 
1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 
1396a(a)(30) [Section 1902(a)(30) of the federal Social Secunty Act]; 42 USC 
Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 
1002.2; 42 CFR Sections 1001.201 thiough 1001.1701; Section 14123. Welfare 
and Institutions Code; and 42 CFR Section 493.1840. 

History 

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 oider transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1065.35. Civil Suit to Enjoin Violations. 

The department shall initiate a civil suit whenever such suit is neces- 
sary to enjoin the violation or threatened violation of chapter 3 (com- 
mencing with section 1 200) of the Business and Professions Code or the 
regulations adopted thereunder. A person or entity against whom a civil 
suit is filed shall have all the rights of defense afforded by California civil 
law. 

NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; Stats. 1 995, c.510, Section 1; and Section 14105, 
Welfare and InstituUons Code. Reference: Stats. 1995. c.510. Section 1; Section 
101 160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 
1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326,Business 
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government 
Code; 42 USC, Section 1395x(s) [Section I861(s) of the Social Security Act]; 42 
United States Code, Section 1 395w-2 [Section 1 846 of the federal Social Security 
Act]; 42 United States Code, Section 1 396a(a)(9)(C) [Section 1902(a)(9)(C) of the 
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec- 
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) 
[Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sec- 
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; 
and 42 CFR Section 493.1840. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 

§ 1065.40. Criminal Sanctions for Unlawful Activity. 

The department may refer for prosecution to the Attorney General's 
office or a District Attorney' s office, when appropriate, any person or en- 
tity it has reason to believe has engaged in any of the unlawful activities 
identified in sections 1280 through 1287, inclusive of the Business and 
Professions Code. A person or entity against whom a criminal action is 
filed shall have all the rights of defense afforded by California criminal 
law. 

NoTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, 
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section 
101 160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 

1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326,Business 
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government 
Code; 42 USC , Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 
United States Code, Section 1395w-2 [Section 1 846 of the federal Social Security 
Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the 
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec- 
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) 
[Section 1 902(p) of the Social Security Act] ; 42 CFR Section 1 002.2; 42 CFR Sec- 
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; 
and 42 CFR Section 493.1840. 

History 
1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 



2. Certificate of Compliance as to 8-28- 
and filed 2-9-98 (Register 98, No. 7). 



order transmitted to OAL 12-24-97 



§ 1065.45. Revocation for Referral of Proficiency Testing 
Samples. 

If the department determines that a laboratory has intentionally re- 
ferred proficiency testing samples to another laboratory for analysis, it 
shall take action to revoke the license/registration or other approval for 
at least one year and may take action to impose any other available sanc- 
tion. 

NOTE: Authority cited: Section 1224. Business and Professions Code; Section 
100275. Health and Safety Code; Stats. 1 995, c.510. Section 1; and Section 14105, 
Welfare and InsUtutions Code. Reference: Stats. 1995. c.510. Section 1; Section 
101160, Health and Safety Code; Secnons 1265, 1267, 1280, 1281, 1282, 1283, 
1284. 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326. Business 
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government 
Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 
United States Code, Section 1395w-2 [Section 1846 of the federal Social Security 
Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the 
federal Social Security Act); 42 United States Code, Section 1396a(a)(30) [Sec- 
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) 
[Section 1 902(p) of the Social Security Act]; 42 CFR Section 1 002.2; 42 CFR Sec- 
tions 1001.201 through 1001. 1701; Section 14123, Welfare and Institutions Code; 
and 42 CFR SecUon 493.1840. 

History 

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97. 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 



§ 1066. Condition Level Requirements. 

(a) Any requirement specified in subsections (b) through (i) shall con- 
stitute a condition level requirement. 

(b) Each clinical laboratory performing clinical laboratory tests or ex- 
aminations classified as of moderate or of high complexity under CLIA 
shall obtain and maintain a valid clinical laboratory license issued pur- 
suant to section 1 265 of the Business and Professions Code. 

(c) Each clinical laboratory shall employ: 

(1) A sufficient number of laboratory personnel with the appropriate 
education and either experience or training to: 

(A) Provide appropriate direction, supervision and consultation; 

(B) Accurately perform tests; and 

(C) Report test results. 

(2) Laboratory personnel who meet the personnel qualifications, du- 
ties, and responsibilities required in CLIA and sections 1203, 1204, 
1206.5, 1207, 1209, 1209.1, 1210, 1270 and 1271 of the Business and 
Professions Code. 

(d) Each clinical laboratory shall: 

( 1 ) Enroll in a proficiency testing program approved by the department 
or by the United States Health Care Financing Administration if required 
to enroll under Business and Professions Code section 1220(a)(2)(A); 
and if required to enroll, demonstrate successful participation, as defined 
under CLIA, for each specialty and subspecialty in which it performs 
clinical laboratory tests or examinations, to the same extent as required 
under CLIA, 

(2) Authorize its proficiency test results to be reported to the depart- 
ment in an electronic format that is compatible with the department' s pro- 
ficiency testing data monitoring system, and 

(3) Authorize the release of proficiency tests results to the public to the 
same extent required by CLIA. 

(e) Each clinical laboratory required to do so under Business and Pro- 
fessions Code secfion 1220(d)(2)(A) shall establish and maintain a pa- 
tient test management system that meets the standards of CLIA; 

(f) Each clinical laboratory required to do so under Business and Pro- 
fessions Code section 1220(d)(2)(B) shall: 

(1) Establish and maintain a quality control program that meets the re- 
quirements of CLIA, 

(2) Perform all clinical laboratory tests or examinaUons classified as 
waived under CLIA in conformity with the manufacturer's instructions. 

(g) Each clinical laboratory required to do so under Business and Pro- 
fessions Code section 1220(d)(2)(C) shall: 



Page 22.8 



Register 98, No. 7; 2-13-98 



Title 17 



State Department of Health Services 



§ 1067.5 



• 



( 1 ) Establish and maintain a comprehensive quaHty assurance pro- 
gram that meets the standards of CLIA, 

(2) Maintain records, equipment, and facilities that are adequate and 
appropriate for the services rendered. 

(3) Be conducted, maintained and operated without injury to the public 
health, and 

(4) If providing cytology services and its licensee ceases operation, 
preserve 

(A) Records, 

(B) Reports, 

(C) Cytology slides, and 

(D) Cell blocks as prescribed in subdivision (g) of section 1271 and 
section 1 274 of the Business and Professions Code. 

(h) Each licensed or registered clinical laboratory shall submit to the 
inspections identified in Business and Professions Code section 1220, 
which inspections may be conducted by department employees or con- 
tractors, or the United States Health Care Financing Administration 
(HCFA), or HCFA agents. The department may conduct announced or 
unannounced inspections of any premises, building, equipment, materi- 
als, records, or information at any reasonable time to secure compliance 
with, or prevent a violation of chapter 3 of division 2 of the B&P Code. 
A clinical laboratory shall permit, as part of this inspection, the depart- 
ment or its contractors or agents to: 

( 1 ) Inspect, photograph, or copy any records, reports, test results, test 
specimens, or other information related to the requirements of chapter 3 
of division 2 of the Business and Professions Code or the regulations 
adopted pursuant thereto. (The laboratory shall make all records and data 
accessible and retrievable within a reasonable time frame during the 
course of the inspection.); 

(2) Secure any sample, photograph, or other evidence from any build- 
ing or premises for the purpose of enforcing chapter 3 of division 2 of the 
Business and Professions Code or the regulations adopted pursuant 
thereto; 

(3) Observe laboratory personnel performing tests (including profi- 
ciency testing), data analysis and reporting; 

(4) Interview all personnel of the clinical laboratory concerning com- 
pliance with chapter 3 of division 2 of the Business and Professions Code 
and the regulations adopted thereunder; 

(5) Upon request, review all information and data necessary to: 

(A) Determine that testing is being performed or the laboratory is be- 
ing operated in a manner that does not constitute an imminent and serious 
risk to public health; 

(B) Evaluate complaints from the pubhc; and 

(C) Determine whether or not the laboratory is performing tests with- 
out a license or registration applicable to the category of tests or examina- 
tions being performed; and 

(6) Provide copies to the department or its contractors or agents of all 
records and data required under chapter 3 of division 2 of the Business 
and Professions Code and the regulations adopted thereunder. 

(i) Each laboratory shall comply with the requirements identified as 
"conditions" in subparts G through P of CLIA. 

NOTH: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; and Stats. 1995, Chapter 510, Section 1. Refer- 
ence: Statutes 1995, Chapter 510, Section 1; and Sections 1203, 1204, 1206.5, 
1207, 1209, 1209.1, 1210, 1220, 1223, 1225 and 1265, Business and Professions 
Code. 

History 

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 



§ 1067. Procedures for the Imposition of Directed Plans of 
Correction. 

(a) The department may impose a directed plan of correction as an al- 
ternative sanction for any clinical laboratory that has condition level defi- 
ciencies. 

(b) If the department is imposing a directed plan of correction, the fol- 
lowing procedures shall apply: 

( 1 ) The department shall give the laboratory a written Notice of Intent 
to impose a directed plan of correction. The Notice of Intent shall include 
the following: 

(A) The condition level deficiency that has been identified, 

(B) The sanction or sanctions that the department proposes to impose 
against the laboratory, 

(C) The rationale for the proposed sanction or sanctions, 

(D) The projected effective date and duration of the proposed sanction 
or sanctions, 

(E) The authority for the proposed sanction or sanctions, and 

(F) The time allowed for the laboratory to respond to the notice. (Dur- 
ing the period specified, the laboratory may submit to the department 
written evidence or other information against the imposition of the pro- 
posed sanction or sanctions.) 

(2) After the period specified in (b)( 1 )(F) has elapsed, the department 
shall give the laboratory a written Notice of Sanction to impose a Di- 
rected Plan of Correcfion that acknowledges any evidence or information 
received from the laboratory and specifies the following: 

(A) The sanction or sancfions to be imposed against the laboratory. 

(B) The authority and rationale for imposing the sancfion or sanctions, 

(C) The effecdve date and duration of sanction, and 

(D) A direction to the laboratory to take specific corrective action 
within specific time frames in order to achieve compliance. 

NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275. Health and Safety Code; and Stats. 1995, c.510. Section 1. Reference: 
Stats. 1995, c.510. Section 1; Section 1310, Business and Professions Code; and 
Sections 11503, 11505 and 11506, Government Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsec- 
tion (b)( 1 )(F), transmitted to OAL 1 2-24-97 and filed 2-9-98 (Register 98, No. 
7). 

§ 1067.5. Procedures for the Imposition of Civil Money 
Penalties. 

(a) The department may impose civil money penalties as an alternative 
sanction for any clinical laboratory that has condition level deficiencies. 

(b) If the department is imposing civil money penalties, the following 
procedures apply: 

(1 ) In determining the amount of the penalty, the department shall take 
into account the following factors: 

(A) The nature, scope, severity, and duration of the deficiency or non- 
compliance. 

(B) Whether the same condition level deficiencies have been identi- 
fied during prior inspections. 

(C) The laboratory's intent or reason for noncompliance. 

(D) The accuracy and extent of laboratory records and their availabil- 
ity to the department or its contractors or agents. 

(2) For a condition level deficiency that does not pose immediate jeop- 
ardy, the range of the penalty amount shall be $50-$3,000 per day of non- 
compliance or per violation. The department may, before any hearing, 
propose to increase the penalty amount into the range specified in (b)(3) 
for a laboratory that has deficiencies which, after imposition of a lower 
penalty amount, become sufficientiy serious to pose immediate jeopardy. 



Page 22.9 



Register 98, No. 7; 2-13-98 



§ 1067.10 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(3) For a condition level deficiency that poses immediate jeopardy, the 
range of the penalty shall be $3,050-$ 10,000 per day of noncompliance 
or per violation. If the immediate jeopardy is removed, but the deficiency 
continues, the department shall shift the penalty amount to the range spe- 
cified in (b)(2). 

(4) The department shall send the laboratory written notice of intent 
to impose a civil money penalty. The notice shall include the following 
information: 

(A) The statutory basis for the penalty, 

(B) The proposed daily or per violation amount of the penalty. 

(C) The factors (as described in paragraph (b)(1) of this section) that 
the department considered, and 

(D) The time allowed for the laboratory to respond to the notice. (Dur- 
ing the period specified, the laboratory may submit to the department 
written evidence or other information against the imposition of the pro- 
posed sanction or sanctions.) 

(5) After the period specified in (b)(4)(D) has elapsed, the department 
shall give the laboratory a written Notice of Sanction that acknowledges 
any evidence or information received from the laboratory and specifies 
the following: 

(A) The sanction or sanctions to be imposed against the laboratory, 

(B) The authority and rationale for imposing the sanction or sanctions, 

(C) The effective date and duration of sanction, and 

(D) A specific statement regarding the laboratory's appeal rights and 
a Notice of Defense in the following form: Unless a written request for 
a hearing signed by the laboratory owner(s) or director(s) is delivered or 
mailed to the department within 15 days after the Notice of Sanction was 
mailed, the department may proceed upon imposition of the sanctions 
identified in the Notice of Sanction without a hearing. A request for a 
hearing may be made by delivering or mailing the enclosed form entitled 
Notice of Defense, or by delivering or mailing a notice of defense as pro- 
vided by section 1 1506 of the Government Code to: The Department of 
Health Services at the address noted on the Notice of Sanction. The labo- 
ratory may, but need not, be represented by counsel at any or all stages 
of the proceedings. 

(6) The laboratory shall have 15 days from the date of receipt of the 
Notice of Sanction to request a hearing by delivering or mailing a Notice 
of Defense. Hearings shall be conducted in accordance with chapter 5 
(commencing with section 11500) of part 1 of division 3 of title 2 of the 
Government Code, except that hearings may be conducted by depart- 
mental hearing officers appointed by the director. 

(7) The effective date of an alternative sanction of a civil money penal- 
ty shall be delayed if the laboratory has appealed and the hearing or the 
hearing decision is pending. 

Note. Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; and Stats. 1995, c.510. Section 1. Reference: 
Stats. 1995, c.510. Section 1; Section 1310, Business and Professions Code; and 
Section 1 1505, Government Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsec- 
tion (b)(4)(D), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, 

No. 7). 

§ 1 067.1 0. Procedures for the Imposition of On-site 
Monitoring. 

(a) The department may require continuous or intermittent monitoring 
of a plan of correction to ensure that the laboratory makes the improve- 
ments necessary to bring it into compliance with the condition level re- 
quirements. 

(b) The laboratory shall pay the costs of on-site monitoring by the de- 
partment. 

(c) If the department imposes on-site monitoring, the following proce- 
dures apply: 

(1) The department shall provide written notice of the following: 



(A) The condition level noncompliance that it has identified, 

(B) The sanction or sanctions that the department proposes to impose 
against the laboratory, 

(C) The rationale for the proposed sanction or sanctions, 

(D) The projected effective date and duration of the proposed sanction 
or sanctions, 

(E) The authority for the proposed sanction or sanctions, and 

(F) The time allowed for the laboratory to respond to the notice. [Dur- 
ing the period specified, the laboratory may submit to the department 
written evidence or other information against the imposition of the pro- 
posed sanction or sanctions.] 

(2) After the period specified in (c)(1)(F) has elapsed, the department 
shall give the laboratory written notice that acknowledges any evidence 
or information received from the laboratory and specifies the following: 

(A) The sanction or sanctions to be imposed against the laboratory, 

(B) The authority and rationale for imposing the sanction or sanctions, 
and 

(C) The effective date and duration of sanction. 

NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; and Stats. 1995, c.510. Section 1. Reference: 
Stats. 1995, c.510. Section 1; Section 1310, Business and Professions Code; and 
Sections 1 1503, 1 1505 and 1 1506, Government Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsec- 
fion (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7). 

§ 1 067.1 5. Procedures for the Imposition of a Temporary 
Suspension of a Laboratory or Clinical 
Laboratory under the Medi-Cal Program. 

(a) The department may impose a Temporary Suspension on a provid- 
er of laboratory services prior to hearing if the laboratory has condition 
level deficiencies or there is immediate jeopardy and in the director's 
opinion such action is necessary to protect the public welfare or the inter- 
ests of the Medi-Cal program. 

(b) If the department is imposing a Temporary Suspension on a provid- 
er of service, the following procedures apply: 

( 1 ) The department shall serve the laboratory with a Notice of Sanction 
which includes the following information: 

(A) The sanction or sanctions to be imposed against the laboratory, 
and 

(B) The effective date and duration of sanction. 

(2) At the same time as the Notice of Sanction is served, the department 
shall serve the laboratory with an Accusation. Included with the Accusa- 
tion is a Notice of Defense in the following form: Unless a written request 
for a hearing signed by the owner(s) or director(s) of the laboratory is de- 
livered or mailed to the department within 15 days after the Notice of 
Sanction and Accusation were served, no hearing shall be held regarding 
the imposition of the sanctions identified in the Notice of Sanction. A re- 
quest for a hearing may be made by delivering or mailing the enclosed 
form entitled Notice of Defense, or by delivering or mailing a notice of 
defense as provided by section 1 1506 of the Government Code to: The 
Department of Health Services at the address noted on the Notice of 
Sanction. The laboratory may, but need not, be represented by counsel 
at any or all stages of these proceedings. 

(3) The laboratory shall have 15 days from the date of receipt of the 
Notice of Sanction to request a hearing by delivering or mailing a Notice 
of Defense. Hearings shall be conducted in accordance with chapter 5 
(commencing with section 1 1500) of part 1 of division 3 of title 2 of the 
Government Code, except that hearings may be conducted by depart- 
mental hearing officers appointed by the director. 

(4) The effective date of a Temporary Suspension of a clinical labora- 
tory or laboratory under the Medi-Cal program shall not be delayed be- 
cause the laboratory has appealed the sanction under (b)(3), above, and 
the hearing or the hearing decision is pending. 



Page 22.10 



Register 98, No. 7; 2-13-98 



Title 17 



State Department of Health Services 



§1079 



NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
100275, Health and Safety Code; and Section 14105, Welfare and Institutions 
Code. Reference: Stats. 1995, c.510. Section 1; Section 1265, Business and Pro- 
fessions Code; Section 14123, Welfare and Institutions Code; 42 United States 
Code, Section 1395w-2 (Section 1846 of the federal Social Security Act); 42 
United States Code, Section 1396a(a)(9) (Section 1902(a)(9)(C) of the federal So- 
cial Security Act); and Sections 1 1503, 1 1505 and 1 1506, Government Code. 

History 

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, 
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 
or emergency language will be repealed by operation of law on the following 
day. 

2. Certificate of Compliance as to 8-28-98 order transiriitted to OAL 12-24-97 
and filed 2-9-98 (Register 98, No. 7). 



Group 3. County and Municipal 
Laboratories 



Article 1 



Official Public Health Laboratory 
Service Required 



§ 1075. Local Health Departments. 

Each local health department shall have available the services of an of- 
ficial public health laboratory. The laboratory of the State Department of 
Health is hereby designated as the official laboratory for all local health 
department jurisdictions not covered by local laboratory service. 
Note: Authority cited for Article 1 : Sections 208, 1000, and 1002 of the Health 
and Safety Code. Reference: Sections 1000 and 1 002, Health and Safety Code. Is- 
suing agency: State Department of Public Health. 

History 

1. Article 1 (§§ 1075 to 1085, inclusive) originally published 8-15-45 (Title 17). 

2. Revised Article 1 (§§ 1075 to 1084, inclusive) filed 10-26-49 (Register 18, No. 
4). 

3. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No. 

4). 

§ 1076. Certificates of Approval Required. 

A certificate of approval issued after inspection by the Department 
shall be required to be in the possession of and be on display in every prin- 
cipal and branch public health laboratory and no such laboratory shall 
continue to operate following receipt of notice of cancellation of any ex- 
isting certificate, or of refusal of the Department to issue a certificate. 

History 

1. Amendment filed 8-16-71 ; effective thirtieth day thereafter (Register 71, No. 
34). 

2. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No. 
4). 

§ 1 076.1 . Public Health Laboratory. 

The official public health laboratory shall consist of a principal public 
health laboratory and may include branch public health laboratories. 

(a) The principal public health laboratory is the laboratory facility that 
provides the major or total laboratory services to a public health depart- 
ment. 

(b) A branch public health laboratory is any laboratory facility that 
provides minor or auxiliary laboratory services. 

NOTE: Authority cited: Sections 208, 1000 and 1002, Health and Safety Code. 
Reference: Sections 1000 and 1002, Health and Safety Code. 

History 
1. New section filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No. 
4). 

§ 1077. Reports Required. 

The following reports shall be transmitted to the Department by all 
laboratories approved under Section 1076. Standard forms shall be used 
if provided by the Department. 

(a) A report shall be made semiannually during the months of January 
and July, of work load data and personnel information as requested by the 
Department. 

(b) A report shall be given within 30 days: 



(1 ) Of any change in the directorship of the laboratory. 

(2) Of any proposed expansion, reduction or shift in laboratory ser- 
vices. 

(3) Of any change in the location of the laboratory. 

(c) Such additional reports shall be made as required by the Depart- 
ment. 

Note; Authority cited: Sections 208 and 1 130, Health and Safety Code. Refer- 
ence: Section 1130, Health and Safety Code. 

History 

1. Amendment filed 8-3-67; effecfive thirtieth day thereafter (Register 67, No. 
31). 

2. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 
34). 

3. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No. 
4). 

4. Editorial con-ecfion of NOTE filed 1 1-5-84 (Register 84, No. 45). 

§ 1078. Minimum Requirements Specified. 

Any laboratory approved under Section 1076 shall meet the following 
minimum requirements: 

(a) Maintain adequate equipment and facilities and sufficient person- 
nel to carry on dependable public health laboratory work. 

(b) Employ procedures, technics, and reporting practices approved by 
the Department. 

(c) Establish and maintain for a minimum of two years adequate record 
systems and files of laboratory work done. 

(d) Conduct, maintain, and operate programs, acceptable to the De- 
partment, for controlling the quality of test performance. 

(e) Demonstrate satisfactory performance in a proficiency testing pro- 
gram approved by the Department. 

(f) Maintain and conduct the laboratory in a manner approved by the 
Department. 

(g) Employ personnel as provided in this article. 

(h) Accept specimens for examination as an aid to patient management 
only from, and issue reports only to, persons licensed under the provi- 
sions of the law relating to the healing arts or their representatives. 

(i) Employ procedures and precautions to provide for the safety and 
health protection of all persons in the laboratory. 

History 

1. Amendment filed 8-16-71; effecfive thirtieth day thereafter (Register 71, No. 
34). 

2. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No. 
4). 

§ 1079. Professional Personnel to Be Certified. 

(a) No person may act as a Public Health Microbiologist in any labora- 
tory certified under Section 1076 who is not in possession of a Public 
Health Microbiologist's Certificate issued by the Department. 

(b) The Department may issue temporary certificates to applicants 
who meet the requirements for admission to the next scheduled examina- 
tion when this is deemed to be reasonably necessary for the provision of 
public health laboratory services. Temporary certificates may not be is- 
sued to applicants who have failed to pass certification examinations. 

(c) Examinations, either written or oral, or both, for the certificate of 
Public Health Microbiologist shall be held as needed and where desig- 
nated by the Department. Such examinations shall be under the supervi- 
sion of the Department. 

(d) The minimum requirements for admission to the examinations for 
a certificate as Public Health Microbiologist shall be as follows: 

( 1 ) Holds an earned doctoral degree from an accredited institution with 
a chemical, physical or biological science as a major, and has completed 
at least one year of postdoctoral laboratory training in medical and public 
health microbiology approved by the Department; or 

(2) A baccalaureate or higher degree with a major in Medical or Public 
Health Microbiology, or equivalent major as determined by the Depart- 
ment, with courses acceptable to the Department, from a college or uni- 
versity accredited by the Western Association of Schools and Colleges 
or an essentially equivalent accrediting agency, as determined by the De- 
partment; and experience represented by at least six months as a Public 



Page 22.11 



Register 98, No. 7; 2-13-98 



§1079 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Health Microbiologist-trainee in a public health laboratory approved by 
the Department for such training; or experience equivalent to this train- 
ing as determined by the Department in a laboratory acceptable to the De- 
partment. 

(e) No person shaH perform any test or make any examination in any 
laboratory certified under Section 1076 unless he is in possession of a 
valid Public Health Microbiologist's certificate or is otherwise approved 
by the Department to perform specified laboratory procedures. 

(f) Every person certified as a Public Health Microbiologist shall re- 
port to the Department within 30 days any change of name or mailing ad- 
dress giving both the old and new names and addresses. 

(g) Certificates may be denied, revoked or suspended for any of the 
following reasons: 

( 1 ) Conviction of a felony or of any misdemeanor involving moral tur- 
pitude, under laws of any State or of the United States, arising out of or 
in connection with public health laboratory practice. The record of con- 
viction or a certified copy thereof shall be conclusive evidence of such 
conviction. 

(2) Violation of any provision of the Business and Professions Code 
governing the practice of medicine and surgery. 

(3) Violation of these regulations. 



(4) Knowingly making a false statement concerning a material matter 
on an application for certification, or on an application for approval as a 
trainee. 

(5) The use of any degree, certificate or title in any manner, which has 
been purchased or procured by barter or any unlawful means or obtained 
from any institution which at the time said degree, certificate or title was 
obtained was not recognized or accredited by the proper authorities of the 
state where said institution was located to give training in the field of 
study in which the degree, certificate or title is claimed. 

(6) The use of drugs or alcoholic beverages to the extent, or in such a 
manner, that such use impairs the ability of the certified person to practice 
his profession with safety to other persons in the laboratory or to the pub- 
lic. 

(h) Proceedings under paragraph (g) above shall be conducted in ac- 
cordance with Chapter 5, Part I, Division 3 of Title 2 of the Government 
Code. 

NOTE: Authority cited: Section 1224, Business and Professions Code; Section 
208, Health and Safety Code. Reference: Section 1270, Business and Professions 
Code; Section 1002, Health and Safety Code. 

History 

1 . Amendment of subsection (d) filed 1 2-12-78; effective thirtieth day thereafter 
(Register 78, No. 50). For prior history, see Register 77, No. 4. 



[The next page is 23.] 



Page 22.12 



Register 98, No. 7; 2-13-98 



Title 17 



State Department of Health Services 



§1126 



2. Amendment of subsection (d)(2) filed 10-24-80; effective thirtieth day thereaf- 
ter (Register 80, No. 43). 

§1080, Professional Training, 

(a) For purposes of this section a person receiving professional train- 
ing required for certification as a Public Health Microbiologist shall be 
designated as a Public Health Microbiologist-trainee. 

(b) The credentials of a Public Health Microbiologist-trainee shall be 
approved by the Department prior to appointment. 

(c) The appointment or separation of a Public Health Microbiologist- 
trainee shall be reported within 5 days to the Department giving the date 
of appointment or separation. 

(d) Laboratories which accept personnel for training as Public Health 
Microbiol ogist-trainees shall be specifically approved for such training 
by the Department. The minimum requirements for approval as training 
laboratories shall be established by the Department. 

(e) A Public Health Microbiologist-trainee shall not be entrusted with 
any microbiological examination except under the supervision of quali- 
fied personnel, nor shall he issue or sign a laboratory report for any test 
which he is scheduled for training for certification as a Public Health Mi- 
crobiologist. 

History 

1. Amendment filed 3-25-57; effective thirtieth day thereafter (Register 57, No. 
5). 

2. Renumbering of Section 1 08 1 and amendment filed 8-16-7 1 ; effective thirtieth 
day thereafter (Register 71, No. 34). 

3. Amendment of subsecdon (e) filed 1-21-77; effecfive thirtieth day thereafter 
(Register 77, No. 4). 

§ 1081, Certain Cultures and Specimens to Be Sent to the 
State Laboratory, 

(a) All laboratories making examinations for identification of typhoid 
carriers shall, in all positive cases, forward to the Department a culture 
of the organism, the isolation of which established the diagnosis. 

(b) Whenever a laboratory receives a specimen for the laboratory diag- 
nosis of suspected human cases of plague or botulism such laboratory 
shall communicate immediately by telephone or telegraph with the De- 
partment for instructions. 

(c) Any other specimens or cultures shall be submitted as required by 
the communicable disease regulations. Sections 2500 to 2699. 

History 

1 . Renumbering of Section 1079 and amendment filed 8-16-7 1 ; effective thirtieth 
day thereafter (Register 71, No. 34). 

2. Amendment of subsection (c) filed 1-21-77; effective thirtieth day thereafter 
(Register 77, No. 4). 

§ 1082, Certain Specimens to Be Sent to Approved 
Laboratories, 

Whenever specimens are taken for laboratory diagnosis of rabies or 
botulism, or for release from isolation of cases of diphtheria, typhoid fe- 
ver, salmonellosis, or shigellosis, they shall be sent by the physician to 
a Public Health Laboratory approved for such work by the Department 
in accordance with Section 1076. 

History 

1 . Amendment filed 3-25-57; effective thirtieth day thereafter (Register 57, No. 
5). 

2. Amendment filed 8-16-71; effecfive thirtieth day thereafter (Register 71, No. 

34). 

3. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No. 
4). 

§ 1083, Inspections to Be Made. 

Laboratories approved under Section 1 076 shall be inspected by a duly 
authorized representative of the Department, for maintenance and con- 
duct in conformity with these regulations. When deemed advisable, the 
Department may send check specimens to local laboratories to evaluate 
the accuracy and precision of specific test performance. 



History 

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 

34). 

§ 1084, Health Departments May Contract with Private 
Laboratories. 

A health officer of a municipality or county may designate any labora- 
tory as an official public health laboratory to perform any of the basic ser- 
vices, as defined under Section 1276(f). Any such laboratory shall be 
subject to the same requirements as an official public health laboratory 
as heretofore provided under Sections 1075 to 1083. inclusive. 

History 

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 
34). 

2. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No. 
4). 



Group 4. Tests for Syphilis Under the 
Premarital and Prenatal Laws 



Article 1. Serologic Tests 

§ 1125, Application Required, 

The director of any laboratory in which performance of serologic tests 
is planned in connection with premarital and prenatal examinations, as 
required by Sections 4300-4309 of the Civil Code and Sections 
3220-3229 of the Health and Safety Code, shall apply to the State De- 
partment of Health for approval to perform these tests. The laboratory di- 
rector shall submit to the State Department of Health, on forms provided 
by the department, such information as may be required by the depart- 
ment to satisfactorily evaluate the personnel, equipment, and scope of ac- 
tivity in relation to these tests. 

NOTE; §§ 11 25 to 1134, inclusive, originally issued under authority contained in 
Section 79.04, Civil Code, and Deering's General Laws, Act 6265. Source of 
§§ 1 125 to 1134, inclusive, is the Rules and Regulations issued by State Depart- 
ment of Health. Additional authority cited for revision of Article 1: Sections 102 
and 208, Health and Safety Code. Reference: Sections 3180-3199 and 
3220-3229, Health and Safety Code. 

History 

1. Amendment filed 10-5-71 as procedural and organizational; effective upon fil- 
ing (Register 71, No. 41). For prior history, see Register 60, No. 19. 

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 
26). 

§ 1 1 26, Approved Tests, 

The serologic tests for syphilis approved by the Department for use in 
connection with legally required premarital and prenatal examinations 
are as follows: VDRL slide. Automated Reagin, Fluorescent Treponemal 
Antibody (absorption), Reagin Screen, and the Rapid Plasma Reagin 
(circle) Card. Any one of these tests shall constitute the "standard test" 
as required by the California Civil Code and California Health and Safety 
Code. 

The serologic tests for rubella approved by the department for use in 
connection with legally required premarital examinations shall be the he- 
magglutination-inhibition (HI) test performed according to the standard 
method of the U.S. Public Health Service, Center for Disease Control, or 
modifications thereof approved by the Center for Disease Control and the 
Department, and such other tests approved by the Center for Disease 
Control and Food and Drug Administration, U.S. Public Health Service, 
as the Department may evaluate and determine to be equal in reliability 
and specificity to the approved hemagglutination-inhibition test. 

Commercially prepared antigens and diagnostic kits utilized for the 
approved rubella tests shall have been evaluated by, and shown to meet 
specifications of the U.S. Public Health Service and such evaluation shall 
be evidenced by a statement on the label of, or accompanying, the prod- 
uct. 

NOTE: Authority cited: Secfion 11426, Government Code; Sections 4300. 4301 , 
4302 and 4304, Cahfornia Civil Code; Sections 102 and 208, Health and Safety 
Code. Reference: Secfions 3180-3199 and 3220-3229, Health and Safety Code. 



Page 23 



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BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



History 

1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 
26). For prior history, see Register 71, No. 34. 

2. Amendment filed 8-17-78; effective thirtietli day thereafter (Register 78, No. 

33). 

§ 1 1 27. Method of Conducting Tests. 

All tests for syphilis must be conducted exactly as outlined by the au- 
thor of the test. All equipment recommended by the author of the test 
must be available in the laboratory before approval can be granted. 

For syphilis serology, the latest United States Department of Health, 
Education and Welfare, Public Health Service publication pertaining to 
the performance of these tests, or its replacement, shall be the reference 
on equipment and methods. 

All tests for rubella must be conducted exactly according to the proto- 
cols for each method or modification that has been approved by the Cen- 
ter for Disease Control and the Department. All necessary equipment for 
the approved rubella test to be performed must be available in the labora- 
tory before approval to perform legally required tests can be granted. 

The references for approved rubella test methods and equipment shall 
be protocols issued by the Center for Disease Control, or the Department, 
or provided by manufacturers for use with commercially distributed 
diagnostic kits or components which have been approved by the Center 
for Disease Control and the Department. 

History 

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No. 
19). See history note to Section 1 125. 

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 
26). 

3. Amendment filed 8-17-78; effective thirtieth day thereafter (Register 78, No. 

33). 

§ 11 28. Evaluation Sera. 

Any laboratory approved to perform premarital and prenatal serologic 
tests must accept and test, evaluation sera provided by the department or 
a proficiency testing service approved by the department, and report test 
results to the department. Any laboratory showing unsatisfactory per- 
formance shall make changes as recommended by the department or dis- 
continue the testing of legally required premarital and prenatal blood 
specimens, and return all outstanding "Marriage Health Certificates." 

History 

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No. 
19). See history note to Section 1 125. 

2. Amendment filed 3-15-66; effective thirtieth day thereafter (Register 71, No. 
7). 

3. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 66, No. 
34). 

§ 1 1 29. Marriage Health Certificates. 

"Marriage Health Certificates" shall be assigned by the State Depart- 
ment of Public Health to an individual laboratory at a specified location, 
and shall be used by no other. These certificates must not be transmitted 
to the physician until the tests have been }ierformed. 

History 
1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 

26). For prior history, see Register 66, No. 7 

§ 1 1 30. Persons Permitted to Perform Tests. 

Only a person who is duly licensed as a physician and surgeon pur- 
suant to Sections 2000-2497 of the Business and Professions Code, or 
duly authorized under the provisions of Chapter 3, Division 2 (commenc- 
ing with Section 1200) of the Business and Professions Code, or who is 
certified under the provisions of Sections 1075-1084 of Title 17 of the 
California Administrative Code, shall be permitted to conduct premarital 
and prenatal serologic tests. 

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: 
Sections 3220, 4300 and 4302, Health and Safety Code. 

History 
1. Amendment filed 2-18-58; effective thirtietli day thereafter (Register 58, No. 
3). See history note to Section 11 25. 



2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 
26). 

§ 1 1 31 . Change of Personnel. 

Within 30 days after new personnel are employed to perform legally 
required prenatal and premarital serologic tests, their names shall be 
transmitted to the State Department of Health. This rule does not apply 
to the rotation of staff members from one phase of laboratory work to 
another. 

History 

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No. 
19). See history note to Section 1 125. 

2. Amendment filed 6-28-73; effecfive thirtieth day thereafter (Register 73, No. 
26). 

§ 11 32. Change of Director or Location. 

Reapplication for approval to perform legally required premarital and 
prenatal serologic tests shall be made when there is a change of laborato- 
ry director or location. 

History 
1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 

26). 

§1133. Advertising Prohibited. 

Laboratories shall not be approved to perform premarital and prenatal 
serologic tests if they advertise the performance of these tests to the lay 
public. 

§ 1134. Withdrawal of Approval. 

Approval granted under this article may be withdrawn following vio- 
lation of any of the provisions of Sections 1125-1 134 of Title 17 of the 
California Administrative Code, Sections 3220-3229 of the Health and 
Safety Code, Sections 4300-4309 of the Civil Code pertaining to the per- 
formance of premarital and prenatal serologic tests and all outstanding 
"marriage health certificates" shall be returned to the State Department 
of Public Health. 

History 

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No. 
19). See history note to Section 1 125. 

2. Amendment filed 3-15-66; effective thirtieth day thereafter (Register 66, No. 
7). 

3. Amendment filed 10-5-71 as procedural and organizational; effective upon fil- 
ing (Register 71, No. 41). 



Group 5. Care of Laboratory Animals 



Article 1. Definitions 

§1150. Definitions. 

(a) For purposes of these regulations, "person" includes: laboratory, 
firm, association, corporation, copartnership, and educational institu- 
tion. 

(b) For purposes of these regulations, "board" means: the State De- 
partment of Health Services. 

(c) For purposes of these regulations, "department" means: the State 
Department of Public Health. 

(d) For purposes of these regulations, "animal" means: any live, 
warm-blooded animal kept or used by any person for the purposes de- 
fined herein. 

(e) For purposes of these regulations, "individual" means: the one 
whom the laboratory, firm, association, corporation, copartnership or 
educational institution designates as being responsible for proper care of 
the animals kept or used for experimentation, demonstration, or test; the 
propriety of the procedures used; and the scientific justification for the 
use of the animals in experiments, demonstrations, or tests. 

History 
1. New Group 5 (§§ 1150 through 1159) filed 3-28-52; effecfive thirtieth day 
thereafter (Register 28, No. 1 ). For history of previous Group 5, see Register 26, 
No. 7. 



Page 24 



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Title 17 



State Department of Health Services 



§1158 



Article 2. Certification Requirements 



§1151. Issuance of the Certificate of Approval. 

(a) All persons desiring to keep or use animals for the study, diagnosis, 
and treatment of human and animal diseases, for education or research 
in the advancement of veterinary, dental, medical, and biological 
sciences for education and research in animal and human nutrition, and 
for the testing and diagnosis, improvement and standardization of labora- 
tory specimens, biologic products, pharmaceuticals and drugs shall make 
application to the department on the forms provided by the department 
for a certification of approval for such activities. They shall supply such 
other information as may be required by the department for the establish- 
ment, and its physical facilities with respect to the care of animals as re- 
lated to the intent and purpose of this law. 

(b) Certificates of approval shall not be issued to any person unless he 
is at the time of application prepared and equipped to keep and use the 
animals in accordance with the provisions of this law, and rules and regu- 
lations of the board adopted in accordance thereof. The department will 
provide anyone contemplating keeping or using animals information 
concerning the requirements and conditions for the compliance with the 
law. 

(c) Each applicant for certification shall designate an individual who 
will be directly responsible for the use and care of animals and for making 
appropriate reports thereof. Such individuals shall occupy a responsible 
position of authority in the applicant organization. A certified institution 
which transfers such responsibility shall immediately notify the depart- 
ment of such fact. The department may deny any application unless it is 
satisfied that the responsible individual so designated is qualified and 
will require that the animals kept or used by the applicant be used and 
cared for in a humane manner acceptable to this department. 

(d) A certificate of approval must be obtained for each address or cam- 
pus where animals are kept or used for the purposes specified in this law. 

(e) A new application or amendment to existing and approved applica- 
tion must be made for any change of the responsible individual, or change 
in location of the laboratory or animal quarters. 

(0 Any major change in equipment or methods of management must 
be approved in advance by the department. 

(g) The certificate of approval or duplicate thereof as supplied by the 
department shall be displayed in a prominent place in the approved ani- 
mal quarters or approved laboratory. 

(h) A certificate of approval shall not be issued unless the conditions 
of the establishment and facilities are such as to reasonably insure that the 
animals kept or used receive humane care and treatment. 

(i) Denial, revocaUon, or suspension of certificates of approval must 
be in accordance with the provisions of the Administrative Procedure 
Act. 



§1152. Fees. 

(a) The application and renewal fees must be in accordance with the 
provisions of Article 5 of Chapter 5 of Division 2 of the Health and Safety 
Code. 

(b) For the purpose of these regulations the fiscal year shall be from 
January 1st to December 3 1 st. 

§ 1 153. Application for Renewal of Certificate of Approval. 

(a) Application for renewal of certificates of approval shall be on 
forms provided by the department. 

(b) Each holder of a certificate applying for renewal of his certificate 
of approval shall be subject to a review of his activities during the pre- 
vious licensing period and to such inspections of his records, premises, 
equipment, and animals as may be determined by the department for con- 
sideration by the board in passing upon the application for renewal. 



(c) Similarly, such licensees shall submit such data and records as may 
be designated by the department. 

§1154. Records. 

Holders of certificates of approval shall keep the following records: 

(a) Monthly census of animals kept according to type; 

(b) Total number of animals used per month according to type; 

(c) Use and disposifion of the animals. 

Such records may be open to inspection by authorized agents of the 
department during the normal working hours of operation. 

Article 3. Minimum Standards 

§ 1 1 55. Care and Treatment of Animals. 

(a) Careful considerafion shall be given to the bodily comfort of such 
animals. They shall be kindly treated, properly fed, and their quarters 
shall be clean, properly lighted and maintained at the proper temperature. 
Excepfion may be made to this rule only with expressed permission of 
the responsible individual. This permission may be granted only when 
the foregoing considerations would defeat the purpose of the work. 

(b) Any operation likely to cause greater discomfort than the attending 
anesthetization shall not be undertaken unul the animal be first rendered 
incapable of perceiving pain. The animals shall be maintained in that 
condifion until the operafion is completed. Exceptions to this rule may be 
made only when provisions for maximum comfort including anesthesia 
would defeat the object of the experiment, and then only with the ex- 
pressed permission of the responsible individual. 

(c) At the conclusion of experiments, the animals must be killed pain- 
lessly or given care to minimize discomfort which is essentially equiva- 
lent, as determined by the department, to that rendered human beings fol- 
lowing an operafion. In any event, animals which have been used for any 
purpose described herein shall not be disposed of as pets, except with the 
expressed permission of the responsible individual. Due consideration in 
this master shall be given to public health and to the animal's welfare. 

§1156. Quarters. 

The animal quarters shall be provided with proper lighting, ventila- 
tion, and heating to maintain comfort of the animal except where the pro- 
visions of Section II 55 otherwise provide. Equipment must be adequate 
for the proper care and treatment of all animals kept or used. Cages, or 
other enclosures, shall be large enough to permit reasonable freedom of 
movement. Adequate facilities shall be provided for keeping animal 
quarters and equipment clean. Overcrowding must be avoided in order 
to limit the transmission of animal diseases. The animals shall be main- 
tained in a room separate from any other activity of the establishment, or 
under other physical conditions satisfactory to the department. 

§1157. Personnel. 

Capable personnel shall be employed for the adequate care and feed- 
ing of the animals. In small, as well as in extensive animal facilities, one 
individual shall be in complete charge of, and therefore, responsible for, 
the entire operation of the unit. Selection of animal caretakers shall be 
made with care. Nonprofessional personnel shall be chosen for their de- 
pendabihty and their liking for animals. The training should include a 
knowledge of the means of transmission of disease and an understanding 
of the precautions necessary to prevent this. Caretakers should be trained 
in recognizing early symptoms of the common diseases of the animals 
under their care. 

§1158. Feeding. 

(a) The animals shall be well fed and shall receive wholesome food 
suitable to the species and shall receive sufficient clean water except 
where special studies require specified diet for the animal. 

(b) Rules and regulations adopted by the board with reference to shel- 
ter, food, sanitation, and the care and treatment of animals shall be promi- 
nently displayed in all animal rooms. 



Page 25 



Register 95, No. 49; 12-8-95 



§1159 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Article 4. Filing of Complaint 

§ 11 59. Filing of a Complaint. 

Anyone who files a complaint to the department against an individual, 
or person, violating this law shall supply in writing specific information 
regarding the alleged violation, or violations. Such complaint shall in- 
clude the time, date, place, individual, or person involved; and the names 
of other witnesses who may be called to testify. This statement must be 
in the form of a sworn affidavit and must be notarized. 



Group 5.5. Methadone Drug Analysis 
Laboratories 



Article 1. Application 

§ 1 1 60. Application of Subchapter. 

Group 5.5 shall apply to all laboratories performing urine testing or 
other body fluids analysis for methadone programs operating in Califor- 
nia. 

NOTE; Authority cited: Sections 208, 1 1881 and 11885, Health and Safety Code. 
Reference: Section 11 885, Health and Safety ("ode. 

History 

1. New Group 5.5 (Articles 1-8, Sections 116(^-1196) filed 11-30-81; effective 
thirtieth day thereafter (Register 81, No. 49). 

2. Editorial coirection of NOTE filed 1 1-6-84 (Register 84, No. 45). 



Article 2. Definitions 

§1161. Methadone Drug Analysis. 

"Methadone drug analysis" means the practical apphcation of special- 
ized devices, instruments and methods by trained laboratory personnel 
to detect the presence of chemical substances named in Section 11 86 in 
samples of urine or other body fluids obtained from persons receiving 
treatment from a methadone program. 

NOTE: Authority cited: Sections 208, 11881 and 1 1885, Health and Safety Code. 
Reference: Section 1 1885, Health and Safety C'ode. 

History 

1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1162. Methadone Drug Analysis Laboratory. 

"Methadone drug analysis laboratory" means a place at which special- 
ized apparatus, instruments and methods are used by trained laboratory 
personnel to detect the presence of chemical substances named in Section 
11 86 in urine or other body fluids obtained from persons receiving treat- 
ment from a methadone program. 

NOTE: Authority cited: Sections 208, 1 1 881 and 1 1 885, Health and Safety Code. 
Reference: Section 11885, Health and Safety C'ode. 

History 
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 63. Methadone Drug Analysis Supervisor. 

"Methadone drug analysis supervisor" means a person, employed by 
a methadone drug analysis laboratory, who is directly responsible for all 
aspects of the performance of methadone drug analysis and for the super- 
vision of personnel who perform such analysis. 

NOTE: Authority cited: Sections 208, 1 1 881 and 1 1885, Health and Safety Code. 
Reference: Section 11885, Health and Safety Code. 

History 

1. Editorial correcfion of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§1164. Method. 

"Method" means the steps used by a trained person to determine the 
presence of drugs in urine or other body iluids. 

NOTE: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. 
Reference: Section 11885, Health and Safety C'ode. 



History 

1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 65. Instrument or Device. 

"Instrument" or "device" means any item or combination of items of 
equipment used to determine the presence of drugs; simple and complex 
devices are included in this meaning. 

NOTE: Authority cited: Sections 208, 1 1 881 and 1 1885, Health and Safety Code. 
Reference: Section 11 885, Health and Safety Code. 

History 

1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 66. Sample or Specimen. 

"Sample" or "specimen" means a representative portion of urine or 
other body fluid or of an artificially constituted material, taken for the 
purpose of determining the presence of drugs. 

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Section 11885, Health and Safety Code. 

History 
1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 67. Department. 

"Department" means the State Department of Health Services. 
NOTE; Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Section 11885, Health and Safety Code. 

History 

1. Editorial correcfion of NOTE filed 11-6-84 (Register 84, No. 45). 

§1168. May, Shall. 

"May" is permissive; "Shall" is mandatory. 
NOTE: Authority cited: Secfions 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Section 1 1885, Health and Safety Code. 

History 
1. Editorial correcfion of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§1169. Methadone. 

"Methadone" means the substance that can be described as 6-dime- 

thyl-amino-4, 4-diphenyl-3-heptanone. Methadone doses are usually 

administered as methadone chloride. 

Note: Authority cited: Secfions 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Section 11885, Health and Safety Code. 

History 

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45). 

§ 1 1 70. Primary Metabolite of Methadone. 

"Primary Metabolite of Methadone" means: 2-ethylidene-l, 5-dime- 
thyl-3, 3-diphenylpyrrolidine. 

NOTE: Authority cited: Secfions 208, 1 1 881 and 1 1885, Health and Safety Code. 
Reference: Section 1 1885, Health and Safety Code. 

History 
1. Editorial correcfion of NOTE filed 11-6-84 (Register 84, No. 45). 



Article 3. Requirements for Methadone 
Drug Analysis Laboratories 

§ 1 1 71 . Licensing Requirement. 

Every methadone drug analysis laboratory performing urine testing or 
other body fluid analysis for any methadone program operating in Cali- 
fornia shall have a valid license issued by the Department in accordance 
with these regulations. 

NOTE: Authority cited: Secfions 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Sections 1 1886 and 1 1887, Health and Safety Code. 

History 
1. Editorial correcfion of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 72. Qualifications for Licensing. 

A methadone drug analysis laboratory meets the qualifications for li- 
censing if it: 

(a) Employs at least one methadone drug analysis supervisor. 

(b) Furnishes the Department with detailed, written descriptions of 
each method it uses for drug analysis. Such description shall clearly de- 
scribe the initial test and confirmatory test methods. 



• 



• 



Page 26 



Register 95, No. 49; 12-8-95 



Title 17 



State Department of Health Services 



§1183 



(c) Maintains an internal quality control program. 

(d) Demonstrates satisfactory performance in an initial proficiency 
testing program conducted by the Department. 

(e) Demonstrates satisfactory performance in a continuing external 
proficiency testing program conducted by or approved by the Depart- 
ment. 

(t") Passes such on-site inspections as the Department may require. 

(g) Demonstrates an ability to meet the requirements of these regula- 
tions. 

NOTE: Authority cited: Sections 208, 11 881 and 1 1885, Health and Safety Code. 
Reference: Sections 1 1885, 1 1886 and 1 1890, Health and Safety Code. 

History 
]. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1173. Qualifications of Methadone Drug Analysis 
Supervisor. 

A methadone drug analysis supervisor shall have the following quali- 
fications: 

(a) Possesses a baccalaureate or higher degree, or an equivalent in 
chemistry, biochemistry, or other appropriate discipline as determined 
by the Department. 

(b) Has two years practical experience in performing drug analysis on 
biological fluids or tissues, such experience to include experience in in- 
terpretation of chromatographic, spectrophotometric and immunochem- 
ical testing results. 

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Section 11 885, Health and Safety Code. 

History 
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 74. Use or Access of Patients. 

A methadone drug analysis laboratory shall not employ or utilize the 
services of a patient of any methadone program in, nor permit any such 
patient access to, any of its activities involving urinalysis or other body 
fluids testing for any methadone program. 

NOTE: Authority cited: Sections 208, 1 1 88 1 and 11 885, Health and Safety Code. 
Reference: Section 1 1885, Health and Safety Code. 

History 

1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 



Article 4. Licensing Procedures 

§ 1 1 75. Qualifying for License. 

Upon receipt of a completed application and upon payment of the re- 
quired fee, the Department shall submit such proficiency test samples 
and perform such examinations as are required for that laboratory to com- 
plete the qualifications. Upon the laboratory's successfully completing 
all the qualifications, the Department shall issue to the applicant labora- 
tory a methadone drug analyses laboratory license. 
NOTE: Authority cited: Secfions 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Sections 11885, 11886 and 11887, Health and Safety Code. 

History 
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 76. Renewal of Licenses. 

A license issued under these regulations shall be renewed annually as 
long as the activity requiring licensure continues. Renewal shall be con- 
tingent upon the laboratory continuing to fulfill the qualifications as set 
forth in these regulations, and is further subject to the following: 

(a) A methadone drug analysis laboratory license shall be vahd from 
July 1 to June 30 of the next succeeding calendar year. Applications for 
renewal and all applicable fees shall be submitted to the Department on 
or before April 1 of each year. 

(b) Failure to apply for renewal shall result in forfeiture after a period 
of three months from the day on which the application for renewal should 
have been submitted, with the exception that the Department may grant 
a temporary extension under special circumstances. 



NOTE: Authority cited: Sections 208, 11 881 and 1 1 885, Health and Safety Code. 
Reference: Section 11887, Health and Safety Code. 

History 

1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1177. Application Forms. 

Application for a license and a renewal thereof, shall be made on forms 
furnished by the Department. The applicant shall set forth all pertinent 
information called for by the form. Application forms may be obtained 
from, and shall be sent to: Clinical Chemistry Laboratory, Department of 
Health Services, 2151 Berkeley Way, Berkeley, CA 94704. 

NOTE; Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Section 11887, Health and Safety Code. 

History 

1. Editorial conection of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 78. Report of Change or Discontinuance. 

The person responsible for the operation of a methadone drug analysis 
laboratory shall report to the Department in writing within 30 days any 
change in ownership, change in supervisorial personnel, changes in 
methods of analysis, change of address or discontinuance of an activity 
authorized under these regulations. 

NOTE: Authority cited: Sections 208, 1 1 881 and 11 885, Health and Safety Code. 
Reference: Section 11885, Health and Safety Code. 

History 
1. Editorial con-ection of NOTE filed 11-6-84 (Register 84, No. 45). 

§ 1 1 79. License Implications. 

Licenses issued under these regulations shall not imply approval of 
anything carried out by a laboratory other than what is specified on the 
Hcense. 

NOTE: Authority cited: Sections 208, 1 1 881 and 1 1 885, Health and Safety Code. 
Reference: Sections 1 1885, 1 1886 and 1 1887, Health and Safety Code. 

History 

1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 80. Display of Licenses. 

Licenses issued under these regulations shall be displayed on request 
to representatives of the Department. 

NOTE; Authority cited: Secdons 208, 1 1 881 and 1 1 885, Health and Safety Code. 
Reference: Sections 1 1885 and 1 1887, Health and Safety Code. 

History 
1. Editorial con-ecfion of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§1181. Fees. 

The annual application fee for a methadone drug analysis laboratory 
license or its renewal shall be $ 100.00. A laboratory operated by the state, 
a county, a city, a city and county, other public agency or a clinical labo- 
ratory licensed pursuant to subdivision (f) of Section 1300 of the Busi- 
ness and Professions Code shall be exempt from the fee. 
NOTE; Authority cited: Secfions 208, 1 1881 and 1 1 885, Health and Safety Code. 
Reference: Section 11 887, Health and Safety Code. 

History 

1. Editorial correcfion of NOTE filed 1 1-6-84 (Register 84, No. 45). 

Article 5. Substances Approved for 

Analysis, Requirements for Collection and 

Handling of Samples 

§1182. Urine. 

The only presently approved body fluid which may be tested for a 
methadone program is urine. 

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Sections 1 1885 and 1 1886, Health and Safety Code. 

History 
1. Editorial correcfion of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§1183. General. 

Urine samples taken for methadone drug analysis shall be collected 
and handled in a manner subject to the approval of the Department. The 
identity and the integrity of the sample shall be maintained through col- 



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§1184 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



lection to analysis and reporting. The only approved urine sample shall 
be one which has been collected under direct observation by a staff mem- 
ber of the methadone program. The sample shall be deposited in a clean 
container. 

NOTE: Authority cited: Sections 208, 11 881 and 1 1885, Health and Safety Code. 
Reference: Section 1 1885. Health and Safety Code. 

History 

1. Editorial coiTection of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 84. Sample Preservation. 

While not in transit to a laboratory, or being analyzed, any urine sam- 
ple not containing a preservative shall be refrigerated. 
NOTE: Authority cited: Sections 208, 11 881 and 1 1 885, Health and Safety Code. 
Reference: Section 1 1885, Health and Safety Code. 

History 

I. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 



shall not be expressed in equivocal terms, such as "possible traces" or 
"plus-minus." 

NOTE; Authority cited: Sections 208, 11 881 and 1 1885, Health and Safety Code. 
Reference: Section 11885, Health and Safety Code. 

History 
1. Editorial con-ection of NOTE filed 1 1-6-84 (Register 84, No. 45). 



Article 6. Methods of Analysis and 
Standards of Performance 

§1185. General. 

All methods used for methadone drug analysis shall be subject to the 
standards as set forth in these regulations. Each licensed methadone drug 
analysis laboratory shall have on file with the Department detailed, cur- 
rent written descriptions of each method it uses for drug screening. Such 
descriptions shall be immediately available to the person performing an 
analysis and shall be available for inspection by the Department on re- 
quest. 

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Section 1 1885, Health and Safety Code. 

History 

1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 86. Standards of Performance. 

The methods of analysis used by a laboratory shall be able to detect the 
following drugs, and at least at the following concentrations, in urine: 



Methadone 

Primary Metabolite of Methadone 

Morphine (total of free and conjugated) 

Codeine 

Amphetamine 

Methamphetamine 

Phenobarbital 

Pentobarbital 

Secobarbital 



2 micrograms per milliliter 
1 microgram per milliliter 
1 microgram per milliliter 

1 microgram per milliliter 

2 micrograms per milliliter 
5 micrograms per milliliter 
1 microgram per milliliter 

1 microgram per milliliter 
1 microgram per milliliter 



NOTE: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. 
Reference: Section 1 1885, Health and Safety Code. 

History 
1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45). 

§1187. Specificity. 

In order to insure adequate specificity, all positive findings, with the 
exception of methadone, shall be confirmed using an alternate method of 
analysis, fundamentally different from that used in the initial test. 
NOTE: Authority cited: Sections 208, 1 1 881 and 1 1885, Health and Safety Code. 
Reference: Section 1 1885, Health and Safety Code. 

History 
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 88. Evaluation of Standards of Performance. 

The ability of methods to meet the standards of performance, as con- 
tained in this Article, shall be subject to evaluation by the Department us- 
ing either a laboratory's internal quality control or external proficiency 
testing results, or both. 

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Section 11885, Health and Safety Code. 

History 
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 89. Expression of Analytical Results. 

All analytical results shall be expressed in terms of the generic or 
chemical name of any drug found to be present, and analytical results 



Article 7. Inspections, Quality Control, 
Proficiency Testing 



§ 1 190. Inspections and Proficiency Testing. 

Licensed methadone drug analysis laboratories and laboratories ap- 
plying for licensure shall be subject to on-site inspections by representa- 
tives of the Department, and shall cooperate in the quality control profi- 
ciency testing program conducted by or approved by the Department. 
These tests shall be used by the Department to evaluate the accuracy of 
the analyses performed by the laboratory. 

Note: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Sections 1 1888 and 1 1890. Health and Safety Code. 

History 
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1 1 91 . Access to Premises. 

The Department may enter any methadone drug analysis laboratory at 
any reasonable time for the purpose of determining whether or not the 
laboratory is complying with the provisions of these regulations. 
NOTE: Authority cited: Sections 208, 1 1 881 and 1 1885, Health and Safety Code. 
Reference: Sections 1 1888 and 1 1890, Health and Safety Code. 

History 
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No 45). 

§ 1 192. Quality Control Program and Proficiency Testing. 

Methods for methadone drug analysis shall be performed in accor- 
dance with the following quality control program: 

(a) Each laboratory shall have its own internal quality control program 
and shall analyze a suitable control sample with each set of 50 samples. 

(b) Each laboratory shall demonstrate acceptable performance in an 
external proficiency testing program. The Department shall submit blind 
proficiency test samples on a random basis to each methadone program 
director; at least 12 samples per quarter shall be submitted. The metha- 
done program director shall, in turn, submit this sample to the methadone 
drug analysis laboratory in a container which is normally used by the pro- 
gram. Each container shall bear identifying numbers and letters that are 
indistinguishable from those used by patients in that program. The profi- 
ciency test samples shall arrive at the laboratory intermingled with other 
regular specimens. When the analysis is completed, the methadone pro- 
gram director shall forward the results of the analysis to the Department. 
The Department shall notify both the methadone program director and 
the director of the methadone drug analysis laboratory of the results of 
the proficiency test at the end of each month. 

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Section 11885, Health and Safety Code. 

History 

1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 

§ 1193. Standard of Performance in Proficiency Testing 
Program. 

Whenever a laboratory fails to correctly analyze at least 90 percent of 
the external proficiency test samples, the Department may take such ac- 
tion as it deems necessary or desirable to correct the source of error. Such 
action may include, but is not limited to, the removal of the laboratory 
from the List of Certified Methadone Laboratories, and, concurrently or 
separately, the commencement of disciplinary proceedings to suspend or 
revoke the license of the laboratory. 

NOTE: Authority cited: Sections 208, 1 1 881 and 1 1885, Health and Safety Code. 
Reference: Sections 11885, 11889 and 11893, Health and Safety Code. 



Page 28 



Register 95, No. 49; 12-8-95 



Title 17 



State Department of Health Services 



§1204 



History 
1 . Editorial coirection of NOTE filed 1 1-6-84 (Register 84, No. 45). 



§ 1 1 94. List of Certified Methadone Laboratories. 

The Department shall compile, maintain and publish a current List of 
Certified Methadone Laboratories, which shall contain all licensed meth- 
adone drug analysis laboratories which are currently able to meet the ac- 
ceptable level of performance required by the provisions of this sub- 
chapter. Whenever the Department determines that any licensed 
laboratory is presently unable to meet the acceptable level of perform- 
ance, the Department shall remove the name of the laboratory from said 
list and notify all programs in the State of such removal. A laboratory so 
removed from the list shall not be restored to the list unless and until the 
laboratory demonstrates to the satisfaction of the Department that it is 
able to meet the acceptable level of performance. 

NOTE: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. 
Reference: Section 1 1889, Health and Safety Code. 

History 
1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 



Group 7. Human Tissue Preservation 



Article 8. Records 



§1195. General. 

Methadone dnig analysis laboratories shall maintain records which 
clearly describe their activities under these regulations. Such records 
shall be available for inspection by the Department upon request. 
NOTE; Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code. 
Reference: Sections 11885 and 11 890, Health and Safety Code. 

History 
] . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 



§ 1196. Methadone Drug Analysis Laboratory Records. 

Each licensed methadone drug analysis laboratory shall keep and pre- 
serve, for at least three years, the following records: 

(a) A record, which is kept current, of persons in its employ who are 
qualified as methadone drug analysis supervisors. This record shall in- 
clude the qualifications of each such person, including education, experi- 
ence, training and performance in examinations and tests conducted by 
the Department. 

(b) A detailed, current written description of each method it uses for 
drug screening. 

(c) Complete records of samples analyzed under these regulations, 
which shall include sample number, date sample received, date sample 
analyzed, results and date results sent to methadone program director. 

(d) Records of the internal quality control program. 

(e) Records of laboratory performance as shown by results in the exter- 
nal proficiency testing program. 

NOTE: Authority cited: Sections 208, 11881 and 1 1885, Health and Safety Code. 
Reference: Section 11 885, Health and Safety Code. 

History 
1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45). 



Group 6. Water Laboratories 

Note: Authority cited: Sections 208 and 4025, Health and Safety Code. Refer- 
ence Section 4025, Health and Safety Code. 

History 

1. New Group 6 (§§ 1 174-11 84) filed 7-27-5 1 ; effective thirtieth day thereafter 
(Register 25, No. 2). 

2. Repealer of Group 6 (Sections 1174-1184) filed 10-22-79; effecfive thirtieth 
day thereafter (Register 79, No. 43). 



Article 1 . Approval 

§1200. Definitions. 

(a) As used in this group, "person" includes teaching institution, uni- 
versity, college, legally licensed hospital, nonprofit blood bank, artery 
bank, eye bank, or other therapeutic service operated by any agency ap- 
proved by the State Director of Health Services. 

(b) As used in this group, "department" means State of California De- 
partment of Health. 

Note: Authority cited for Group 7: Sections 102 and 208, Health and Safety Code 

History 

1. New Group 7 (Sections 1200 through 1205) filed 4-30-59; effective thirtieth 
day thereafter (register 59, No. 7). 

2. Editorial Correction (Register 73, No. 26). 

§ 1201. Approval Required for Tissue Preservation. 

No person shall collect, process, store, or distribute human tissues ob- 
tained in accordance with Sections 7 1 00 or 7 1 1 5 of the Health and Safety 
Code, or Section 20 of the Probate Code, unless such person shall have 
received approval from the departinent. 

§ 1 202. Provisions for Approval. 

(a) An application for approval shall be made to the department, which 
shall include the following items. 

( 1 ) Complete and detailed description of the methods, equipment, and 
technics used in relation to each tissue which is to be processed. 

(2) The name and address of the person owning the place, establish- 
ment, or institution, in which the processing is to be carried on. 

(3) The name and address of the director v/ho shall be a duly licen.sed 
physician and surgeon in the State of California. 

(4) Kinds of tissues to be processed. 

(5) Such additional information as the department may require in order 
to determine compliance with these regulations. 

(b) The operation of the tissue bank shall be under the direct supervi- 
sion of a physician and surgeon duly licensed in this State. 

(c) The person shall be prepared to begin operations at the time appli- 
cation for approval is submitted. 

(d) Application will be approved only when establishment and the 
methods used are such that the tissues processed will not be contami- 
nated, dangerous, or harmful. 

(1) Representative samples shall be provided for the department of 
each lot of tissues, if requested by the department, for the purpose of 
checking sterility, quality, or other factor. 

(2) Any duly authorized representative of the department shall have 
free access to the establishment and the records thereof at all reasonable 
hours for the purpose of ascertaining compliance with these regulations. 

(e) Approval may be granted only for the processing of tissues for 
which there is scientific evidence of therapeutic value and for which 
methods of preservation have been developed. 

(f) Renewal of Approval. 

(1) The department shall issue renewal notices annually prior to the 
end of each calendar year. 

(2) Each person on applying for renewal shall review his activities in 
the field for the preceding year if requested to do so by the department. 

(g) There is no fee required in connection with this approval, or with 
renewal of approval. 

§ 1203. Exemptions from Approval. 

This group does not apply to autogenous tissue grafting, or to homo- 
grafts where tissues are obtained from living donors, or to other biologic 
products as defined in Section 1601 of the Health and Safety Code. 

§1204. Records. 

(a) The director or supervisor of approved tissue processing programs 
shall keep records of all tissues processed. 



Page 29 



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§1205 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(b) Records may be designated by number (instead of by name of do- 
nor) to conform with individual specimens or lots of tissue. 

(c) Records shall contain the following data: 

( 1 ) Name and address of institution from which material was obtained, 
also name of physician responsible for procurement. 

(2) Date and hour of death of donor. 

(3) Cause of death and age of donor and. when available, pathologic 
results including autopsy reports. 

(4) Date and hour of obtaining tissue. If more than four hours post mor- 
tem, state whether refrigeration was used and, if so, give length of time 
and temperature. 

(5) Date and method of processing tissue, if applicable. 

(6) Date final storage begins. 

(7) Date and place of use. 

(8) Results of tests for contamination and other examinations. 

(9) Pertinent laboratory data, including serologic tests for syphilis, 
from donor. Prospective donors with histories of hepatitis shall not be ac- 
cepted. 

(10) Information relating to consent or authorization. 

(d) Unless otherwise required by other provisions of law, all records 
and information shall be retained for not less than two (2) years. 

§1205. Labels. 

(a) A method which will positively identify each specimen during the 
period from procurement to the beginning of final storage shall be placed 
in effect by each person. 

(b) The final label shall show: 

( 1 ) The name of the product, and method used in processing. 

(2) A number which will identify the processing information related 
to the specimen. 

(3) A date prior to which use must be made of the product, or prior to 
which use of the product is recommended, whichever is applicable. 

(4) Name and address of the processor. 

(5) If temperature is a factor in preservation, the temperature range 
within which deterioration is avoided shall be specified. 

(6) Other data descriptive of the product may also be included in the 
label. 

(7) Directions for reconstitution of the product, and preparation for its 
use may be included in the label or in an accompanying circular. 

(8) Altered or supplementary labels shall not be used. 

Group 8. Forensic Alcohol Analysis and 
Breath Alcohol Analysis 



Article 1 . General 

§1215. Authority. 

Chapter 5 Sections 436.50-436.63 of Part 1 of Division 1 of the Health 
and Safety Code. 

NOTE: Authority cited: Sections 102 and 208, Health and Safety Code. 

History 

1. New Group 8 (Sections 1215, 1215.1, 1216, 1216.1, 1217, 1217.1 through 
1217.8, 1218, 1218.1 and 1218.2) filed 8-1 0-70; effective thirtieth day thereaf- 
ter (Register 70, No. 33). 

§1215.1. Definitions. 

(a) 'Alcohol" means the unique chemical compound, ethyl alcohol, 
with the exception that reference in these regulations to compounds to be 
avoided as skin antiseptics includes the generic class of organic com- 
pounds known as alcohols. 

(b) "Forensic Alcohol Analysis" means the practical application of 
specialized devices, instruments, and methods by trained laboratory per- 
sonnel to measure the concentration of ethyl alcohol in samples of blood, 
breath, urine, or tissue of persons involved in traffic accidents or traffic 
violadons. 



(c) "'Breath Alcohol Analysis" means analysis of a sample of a per- 
son's expired breath, using a breath testing instrument designed for this 
purpose, in order to determine the concentration of ethyl alcohol in the 
person's blood. 

(d) "Concentration" means the weight amount of alcohol contained in 
a unit volume of liquid or a unit volume of gas under specified conditions 
of temperature and pressure; in the case of a solid fissue specimen, "con- 
centrafion" means the weight amount of alcohol contained in a unit 
weight of specimen. 

(e) "Forensic Alcohol Laboratory" means a place at which specialized 
apparatus, instruments, and methods are used by trained laboratory per- 
sonnel to measure the concentration of alcohol in samples of blood, 
breath, urine, or tissue of persons involved in traffic accidents or in traffic 
violations; this may be an activity of a laboratory engaged in activities 
other than alcohol analysis. 

(f) "Forensic Alcohol Supervisor" means a person employed by a fo- 
rensic alcohol laboratory who can be responsible for all aspects of the 
performance of forensic alcohol analysis and for the supervision of per- 
sonnel who perform such analysis. 

(g) "Forensic Alcohol Analyst" means a person employed by a foren- 
sic alcohol laboratory who performs the technical procedures of forensic 
alcohol analysis. 

(h) "Forensic Alcohol Analyst Trainee" means a person employed by 
a forensic alcohol laboratory for the purpose of receiving comprehensive 
practical experience and instruction in the technical procedures of foren- 
sic alcohol analysis under the supervision of a forensic alcohol supervi- 
sor or forensic alcohol analyst. 

(i) "Method" means the steps used by a trained person to make a mea- 
surement of alcohol concentrafion. 

(j) "Instrument" or "Device" means any item or combinafion of items 
of equipment used to make a measurement of alcohol concentration; sim- 
ple and complex devices are included in this meaning. 

(k) "License" means a document issued by the State Department of 
Health to a laboratory to perform the tests referred to in the Health and 
Safety Code, Sections 436.51 and 436.52. 

(/) "Sample" or "Specimen" means a representative portion of breath, 
blood, urine, or tissue or of an arfificially constituted material, taken for 
the purpose of measuring its alcohol concentration. 

(m) "Alveolar" refers to the smallest air sacs in the lungs and to that 
portion of the expired breath which is in equilibrium with respect to alco- 
hol with the immediately adjacent pulmonary blood. 

(n) "Department" means the California State Department of Health 
and its duly authorized representatives. 

History 

1 . Amendment of subsections (b), (c), (d) and (e) filed 1 0-9-70; effective thiitieth 
day thereafter (Register 70, No. 41). 

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 



Article 2. Requirements for Forensic 
Alcohol Laboratories 

§ 1216. Authorization Requirement. 

(a) Every laboratory performing forensic alcohol analysis shall have 
a valid license issued in accordance with the provisions of these regula- 
tions. 

(1) Forensic alcohol analysis shall be performed only by persons who 
meet the qualifications set forth in these regulations for forensic alcohol 
supervisors, forensic alcohol analysts, or forensic alcohol analyst train- 
ees. 

(A) A trainee may perform forensic alcohol analysis only under the su- 
pervision of a forensic alcohol supervisor or forensic alcohol analyst. 

(2) The Department shall not be limited by these regulations in per- 
forming functions in administration of the alcohol analysis and licensing 
program. 



Page 30 



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Title 17 



State Department of Health Services 



§ 1217.1 



History 
1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 



§ 1 21 6.1 . Qualifications for Licensing. 

(a) A laboratory meets the qualifications for licensing by: 

( 1 ) Employing at least one forensic alcohol supervisor. If forensic al- 
cohol analysis is performed by persons other than forensic alcohol super- 
visors, such persons shall meet the qualifications set forth in these regula- 
tions for forensic alcohol analysts or forensic alcohol analyst trainees; 

(2) Maintaining a quality control program in forensic alcohol analysis 
procedures; 

(3) Demonstrating satisfactory performance in a proficiency testing 
program conducted by or approved by the Department; 

(4) Passing such on-site inspections as the Department may require; 

(5) Showing ability to meet the requirements set forth in these regula- 
tions. 

(b) These qualifications shall be maintained at all times by each li- 
censed laboratory. 

(c) The Department may deny a license or renewal thereof, or take dis- 
ciplinary action against a licensee, for failure to maintain these qualifica- 
tions in a manner which meets the Department's standards for approval. 

(d) Whenever a licensed laboratory employing only one forensic alco- 
hol supervisor loses that person, the Department may upon petition of the 
laboratory extend the license for a period not exceeding 90 days during 
which time the laboratory shall hire another forensic alcohol supervisor. 

(1) Such an extension shall be contingent on the laboratory's having 
in its employ at least one forensic alcohol analyst and upon the laborato- 
ry's successfully demonstrating to the Department continued compe- 
tence in forensic alcohol analysis through such proficiency tests, exami- 
nations, and on-site inspections as the Department may require. 

(e) A forensic alcohol supervisor is a person who meets the following 
qualifications: 

(1) Possesses a baccalaureate or higher degree, or an equivalent, in 
chemistry, biochemistry, or other appropriate discipline as determined 
by the Department; 

(2) Has two years of experience in performing forensic alcohol analy- 
sis, such experience to include experience in interpretation and correla- 
tion of alcohol analyses with subjective observations of the demeanor 
and behavior of persons who have ingested known amounts of ethyl alco- 
hol; or, in lieu of such two years of experience, satisfactorily completes 
a training course approved by the Department, such training course to in- 
clude at minimum the following schedule of subjects: 

(A) Value and purpose of forensic alcohol analysis, including breath 
alcohol analysis; 

(B) Physiological action of alcohol; 

(C) Pharmacology and toxicology of alcohol; 

(D) Laboratory methods of alcohol analysis; 

(E) Instruments and procedures for breath alcohol analysis; 

(F) Practical laboratory demonstration of the student's ability to per- 
form alcohol analysis; 

(G) Interpretation of results of alcohol analysis, including correlation 
of alcohol analyses with subjective observations of the demeanor and be- 
havior of persons who have ingested known amounts of alcohol; 

(H) Court testimony; 

(I) Court decisions regarding chemical tests of alcohol to determine al- 
cohol influence; and 

(J) Requirements of these regulations; 

(3) Successfully demonstrates accuracy in the analysis of proficiency 
test samples submitted by the Department, and successfully passes ex- 
aminations prescribed by the Department; 

(4) Demonstrates the ability to adhere to the provisions of these regula- 
tions; or (in lieu of ( 1 ) and (2) above) 

(5) Either is a person who, prior to January 1,1971, qualified as direc- 
tor of a clinical laboratory operating under the provisions of the Califor- 
nia Business and Professions Code, or is a person who, for a period of one 



year prior to January 1 , 1 97 1 , has been employed in the activities of a fo- 
rensic alcohol supervisor. 

(f) A forensic alcohol analyst is a person who meets the following 
quaHfications: 

( 1 ) Successfully completes at least 60 semester-hours, or their equiva- 
lent in quarter-hours, of college level courses, including 8 hours of gen- 
eral chemistry and 3 hours of quantitative analysis; 

(2) Successfully completes a training period in alcohol analysis on fo- 
rensic or clinical specimens in a forensic alcohol laboratory or in a clini- 
cal laboratory; 

(3) Performs during the training period a minimum of 25 analyses of 
alcohol concentration in blood samples, at least half of which contain al- 
cohol; 

(4) Successfully demonstrates accuracy in the analysis of proficiency 
test samples submitted by the Department, and successfully passes ex- 
aminations prescribed by the Department; 

(5) Demonstrates ability to adhere to the provisions of these regula- 
tions; or (in lieu of (1), (2), and (3) above) 

(6) Either is a person who, prior to January 1 , 1 97 1 , was a clinical labo- 
ratory technologist licensed under the provisions of the California Busi- 
ness and Professions Code, or is a person who, for a period of one year 
prior to January 1 , 1 97 1 , has been employed in the activities of a forensic 
alcohol analyst. 

(g) A forensic alcohol analyst trainee is a person who meets the follow- 
ing qualifications: 

(1) Meets the educational quahfication set forth as (1) for a forensic 
alcohol analyst; 

(2) Is employed by a licensed forensic alcohol laboratory. 

History 

1 . Amendment of subsection (c)( 1 ) filed 1 0-9-70; effective thirtieth day thereafter 
(Register70, No. 41). 

2. Amendment of subsection (b)(2) filed 8-2-72; effective thirtieth day thereafter 
(Register 72, No. 32). 

3. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

4. Editorial correction (Register 76, No. 24). 



Article 3. Licensing Procedures 

§ 1217. Forensic Alcohol Laboratory License. 

(a) Upon receipt of a completed application which shows ability to 
meet the requirernents set forth in these regulations, and upon payment 
of any required fee, the Department shall submit such proficiency test 
samples and perform such examinations as are required for that laborato- 
ry to complete the qualifications. 

(b) Upon the laboratory's successfully completing all the qualifica- 
tions, the Department shall issue to the applicant laboratory a forensic al- 
cohol laboratory license. 

History 
1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

§ 1 21 7.1 . Renewal of Licenses. 

(a) Licenses under these regulations shall be renewed as required by 
the Department as long as the activity requiring authorization continues. 
Renewal shall be contingent upon the laboratory continuing in the quali- 
fications set forth in these regulafions. 

(1) A forensic alcohol laboratory license shall be valid from January 
1 to December 3 1 of a calendar year. Applicafions for renewal and appli- 
cable fees shall be submitted to the Department on or before October 1 
of each year. 

(2) Failure to apply for renewal shall result in forfeiture after a period 
of three months from the day on which the applicadon for renewal should 
have been submitted, with the exception that the Department may grant 
a temporary extension under special circumstances. 

(3) An application for renewal shall not list as a forensic alcohol ana- 
lyst trainee any person who fails to comply with the requirements of Sec- 



Page 31 



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§ 1217.2 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



tion 1 2 1 6. 1 (f) (4) within a period of one year after he was first listed with 
the Department as a trainee. The Department may extend this period for 
a justifiable reason, such as illness. 

History 

1 . New subsection (c) filed 4-7-71 ; effective thirtieth day thereafter (Reeister 71 , 
No. 15). 

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

§1217.2. Application Forms. 

Application for a license and renewal thereof, shall be made on forms 
furnished by the Department. The applicant shall set forth all pertinent 
information called for by the form. 

§ 1 21 7.3. Report of Change or Discontinuance. 

(a) A person responsible for the operation of a forensic alcohol labora- 
tory shall report to the Department in writing within 30 days any change 
in qualified personnel who may be performing forensic alcohol analysis, 
change of ownership, change of address or change or discontinuance of 
an activity authorized under these regulations. 

(b) Such reports shall be made on forms furnished by the Department 
and shall set forth all pertinent information called for by the form. 

(c) Persons who formerly qualified as forensic alcohol supervisors or 
forensic alcohol analysts in another laboratory may be required to dem- 
onstrate again their ability to meet the requirement of Section 1216.1 (e) 
(3) or 1216.1 (f) (4) using the method, apparatus and facilities of the fo- 
rensic alcohol laboratory which newly lists them in such a Report of 
Change or Discontinuance. 

History 

1. Amendment filed 10-9-70; effective thirtieth day thereafter (Register 70, No. 
41). 

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

3. Editorial conection (Register 76, No. 24). 

§ 1217.4. License Implications. 

Licenses issued under these regulations shall not imply approval of 
anything carried out by a laboratory other than what is specified on the 
document. 

§1217.5. Licensing Records. 

Forensic Alcohol Laboratory Licenses shall become part of permanent 
records available to the courts for legal proceedings or to the Department. 

§ 1217.6. Inspection and Additional Requirements. 

(a) Display of Licenses. Licenses issued under these regulations shall 
be displayed on request to representatives of the Department. 

(b) Access to Premises. The Department may enter at all reasonable 
times upon any laboratory for the purpose of determining whether or not 
there is compliance with the provisions of these regulations. 

§ 1 217.7. Surveys and Proficiency Tests. 

(a) Laboratories having been licensed or applying for licensing as fo- 
rensic alcohol laboratories shall be subject to on-site surveys by repre- 
sentatives of the Department, the results of which must meet the require- 
ments of these regulations, and shall accept periodic evaluation samples, 
perform analyses and report the results of such analyses to the Depart- 
ment. 

(b) These analytical results shall be used by the Department to evaluate 
the accuracy of the forensic alcohol analyses performed by the laborato- 
ry, and the results must meet the requirements of these regulations. 

History 
1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

§ 1 21 7.8. Fees and Other Procedures. 

The annual application fee for a Forensic Alcohol Laboratory License 
or its renewal shall be one hundred dollars ($100). A laboratory operated 
by the state, city or county or other public organization shall be exempt 
from the annual application fee requirement. Other procedures in the ad- 



ministration of these regulations shall be carried out as set forth in Chap- 
ter 5 (commencing with section 436.50) of Part 1 of Division 1 of the 
Health and Safety Code. Such other procedures include suspension or re- 
vocation of license, denial of license, and disciplinary action. 

Article 4. Training of Personnel 



§1218. Training Program Approval. 

Any organization, laboratory, institution, school, or college conduct- 
ing a course of instruction for persons to qualify under these regulations 
shall submit a course summary and list of instructors and their qualifica- 
tions to the Department for approval. 

§1218.1. Additional Requirements. 

At the discretion of the Department, any phase or portion of a training 
program shall be subject to alteration in an effort to update the program 
as technological advances are made or if a portion has been judged inap- 
propriate. 

§1218.2. Contracts. 

The Department may contract with persons it deems qualified to ad- 
minister such practical tests and written or oral examinations as may be 
required under these regulations. This section shall not be construed to 
authorize the delegation of any discretionary functions conferred on the 
Department by law, including, but not limited to, the evaluation of tests 
and examinations. 



• 



Article 5. 



Collection and Handling of 
Samples 



§1219. General. 

Samples taken for forensic alcohol analysis and breath alcohol analy- 
sis shall be collected and handled in a manner approved by the Depart- 
ment. The identity and integrity of the samples shall be maintained 
through collection to analysis and reporting. 

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: 
Section 436.50, Health and Safety Code. 

History 

1. New Article5( 1219, 1219. 1,1219.2, 1219.3), filed 10-9-70; effective thirtieth 

day thereafter (Register 70, No. 41). 
2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 

48). 

§ 1219.1. Blood Collection and Retention. 

(a) Blood samples shall be collected by venipuncture from living indi- 
viduals as soon as feasible after an alleged offense and only by persons 
authorized by Section 13354 of the Vehicle Code. 

(b) Sufficient blood shall be collected to permit duplicate determina- 
tions. 

(c) Alcohol or other volatile organic disinfectant shall not be used to 
clean the skin where a specimen is to be collected. Aqueous benzalko- 
nium chloride (zephiran), aqueous merthiolate or other suitable aqueous 
disinfectant shall be used. 

(d) Blood samples shall be collected using sterile, dry hypodermic 
needles and syringes, or using clean, dry vacuum type containers with 
sterile needles. Reusable equipment,if used, shall not be cleaned or kept 
in alcohol or other volatile organic solvent. 

(e) The blood sample shall be deposited into a clean, dry container 
which is closed with an inert stopper. 

( 1 ) Alcohol or other volatile organic solvent shall not be used to clean 
the container. 

(2) The blood shall be mixed with an anticoagulant and a preservative. 

(f) When blood samples for forensic alcohol analysis are collected 
post-mortem, all practical precautions to insure an uncontaminated sam- 
ple shall be employed, such as: 

(1) Samples shall be obtained prior to the start of any embalming pro- 
cedure. Blood samples shall not be collected from the circulatory system 



Page 32 



(4-1- 



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§ 1220.3 



effluent during arterial injection of embalming fluid. Coroner's samples 
do not need a preservative added if stored under refrigeration. 

(2) Care shall be taken to avoid contamination by alcohol from the gas- 
trointestinal tract directly or by diffusion therefrom. The sample shall be 
taken from a major vein or the heart. 

(g) In order to allow for analysis by the defendant, the remaining por- 
tion of the sample shall be retained for one year after the date of collec- 
tion. 

(1) In coroner's cases, blood samples shall be retained for at least 90 
days after date of collection. 

(2)Whenever a sample is requested by the defendant for analysis and 
a sufficient sample remains, the forensic alcohol laboratory or law en- 
forcement agency in possession of the original sample shall continue 
such possession, but shall provide the defendant with a portion of the re- 
maining sample in a clean container together with a copy or transcript of 
the identifying information carried on the original sample container. 

History 

1 . Amendment of subsection (d) filed 4-7-7 1 ; effective thirtieth day thereafter 
(Register 71, No. 15). 

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

§ 1219.2. Urine Collection and Retention. 

(a) The only approved urine sample shall be a sample collected no 
sooner than twenty minutes after first voiding the bladder. 

(b) The specimen shall be deposited in a clean, dry container which 
also contains a preservative. 

(c) In order to allow for analysis by the defendant, the remaining por- 
tion of the sample shall be retained for one year after the date of collec- 
tion. 

( 1 ) Whenever a sample is requested by the defendant for analysis and 
a sufficient sample remains, the forensic alcohol laboratory or law en- 
forcement agency in possession of the original sample shall continue 
such possession, but shall provide the defendant with a portion of the re- 
maining sample in a clean container together with a copy or transcript of 
the identifying information carried by the original sample container. 

History 

1 . Amendment of subsection (a) filed 4-7-7 1 ; effective thirtieth day thereafter 
(Register 71, No. 15). 

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

§ 1 21 9.3. Breath Collection. 

A breath sample shall be expired breath which is essentially alveolar 
in composition. The quantity of the breath sample shall be established by 
direct volumetric measurement. The breath sample shall be collected 
only after the subject has been under continuous observation for at least 
fifteen minutes prior to collection of the breath sample, during which 
time the subject must not have ingested alcoholic beverages or other 
fluids, regurgitated, vomited, eaten, or smoked. 

History 
1. Amendment filed 4-7-71; effective thirtieth day thereafter (Register 71, No. 

15). 



Article 6. 



Methods of Forensic Alcohol 
Analysis 



§1220. General. 

(a) All laboratory methods used for forensic alcohol analysis shall be 
subject to standards set forth in this Article. 

(b) Each licensed forensic alcohol laboratory shall have on file with 
the Department detailed, up-to-date written descriptions of each method 
it uses for forensic alcohol analysis. 

( 1 ) Such descriptions shall be immediately available to the person per- 
forming an analysis and shall be available for inspection by the Depart- 
ment on request. 



(2) Each such description shall include the calibration procedures and 
the quality control program for the method. 

NOTE: Authority cited: Sections 102 and 208. Health and Safety Code. Reference: 
Section 436.50. Health and Safety Code. 

History 

1. New Anicle 6 ( 1220, 1220.1 through 1220.4) filed 10-9-70; effective thirtieth 
day thereafter (Register 70, No. 41). 

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

§ 1 220.1 . Standards of Performance. 

(a) Methods for forensic alcohol analysis shall meet the following 
standards of performance: 

(1) The method shall be capable of the analysis of a reference sample 
of known alcohol concentration within accuracy and precision limits of 
plus or minus 5 percent of the value; these limits shall be applied to alco- 
hol concentrations which are 0.10 grams per 100 milliliters or higher; 

(2) The method shall be capable of the analysis of ethyl alcohol with 
a specificity which is adequate and appropriate for traffic law enforce- 
ment. 

(3) The method should be free from interference from anticoagulants 
and preservatives added to the sample; 

(4) Blood alcohol results on post-mortem samples shall not be re- 
ported unless the oxidizable substance is identified as ethyl alcohol by 
qualitative test; 

(5) The method shall give a test result which is always less than 0.01 
grams of alcohol per 100 milliliters of blood when living subjects free of 
alcohol are tested. 

(b) The ability of methods to meet the standards of performance set 
forth in this Section shall be evaluated by the Department using a labora- 
tory's proficiency test results and such ability must meet the require- 
ments of these regulations. 

History 
I . Amendment filed 1 1-24-75; effecfive thirtieth day thereafter (Register 75, No. 
48). 

§ 1 220.2. Standards of Procedure. 

(a) Methods for forensic alcohol analysis shall meet the following 
standards of procedure: 

( 1 ) The method shall be calibrated with standards which are water so- 
ludons of alcohol. 

(A) Such alcohol solutions are secondary standards. 

(B) Each forensic alcohol laboratory shall establish the concentration 
of each lot of secondary alcohol standards it uses, whether prepared or 
acquired, by an oxidimetric method which employs a primary standard, 
such as United States National Bureau of Standards potassium dichro- 
mate; 

(2) The procedure shall include blank and secondary alcohol standard 
samples at least once each day that samples are subjected to forensic alco- 
hol analysis. 

(A) The blank and secondary alcohol standard samples shall be taken 
through all steps of the method used for forensic alcohol analysis of sam- 
ples. 

(3) The procedure shall also include analysis of quality control refer- 
ence samples as described in Section 1220.3 and shall include at least du- 
plicate analyses of samples for forensic alcohol analysis. 

(A) A quality control reference sample shall not be taken from the 
same lot of alcohol solution which is used as a secondary alcohol stan- 
dard. 

(4) Alcohols or other volatile organic solvents shall not be used to 
wash or rinse glassware and instruments used for alcohol analysis; 

(5) All instruments used for alcohol analysis shall be in good working 
order and routinely checked for accuracy and precision. 

History 

1. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75. No. 

48). 

§1220.3. Quality Control Program. 

(a) Methods for forensic alcohol analysis shall be performed in accor- 
dance with the following quality control program: 



Page 33 



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BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



( 1 ) For each method of forensic alcohol analysis it performs, each fo- 
rensic alcohol laboratory shall make or acquire a suitable quality control 
reference material containing alcohol, a sample of which it shall analyze 
along with each set of samples; the alcohol concentration in the reference 
material shall be between 0.10 and 0.20 grams per 100 milliliters of liq- 
uid; 

(2) For each lot of quality control reference material, the laboratory 
shall determine a mean value of at least 20 replicate analyses, at a rate of 
no more than 2 analyses per day, with the method used for analysis of 
samples for forensic alcohol analysis; 

(3) Acceptable limits of variation for the method shall be set as fol- 
lows: 

(A) The lower limit shall be calculated by subtracting, from the mean 
value, 0.01 grams per 100 milliliters; 

(B) The higher limit shall be calculated by adding, to the mean value, 
0.01 grams per 100 milliUters; 

(4) At least one sample of the quality control reference material shall 
be analyzed with each set of samples analyzed for the purpose of forensic 
alcohol analysis; 

(5) Whenever analysis of the quality control reference material is out- 
side the acceptable limits, the method shall be regarded to be in error, and 
a forensic alcohol supervisor shall take remedial action to investigate and 
correct the source of error; 

(6) Until such time as the error has been corrected, as shown by return 
of the analysis of the quality control reference material to values within 
the acceptable limits, no samples shall be analyzed for the purpose of fo- 
rensic alcohol analysis. 

History 

I . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

§ 1220.4. Expression of Analytical Results. 

(a) With the exception of tissue analysis, all analytical results shall be 
expressed in terms of the alcohol concentration in blood, based on the 
number of grams of alcohol per 100 milliliters of blood. 

(1 ) The symbols, grams %, %, and % (W/V), shall be regarded as ac- 
ceptable abbreviations of the phrase, grams per 100 milliliters of liquid. 

(b) Analytical results shall be reported to the second decimal place, de- 
leting the digit in the third decimal place when it is present. 

(c) Blood alcohol concentrations less than 0.01% in living subjects 
may be reported as negative. 

(d) Blood alcohol concentrations less than 0.02% on post-mortem 
blood samples may be reported as negative. 

(e) A urine alcohol concentration shall be converted to an equivalent 
blood alcohol concentration by a calculation based on the relationship: 
the amount of alcohol in 1 .3 milliliters of blood is equivalent to the 
amount of alcohol in 1 milliliter of urine. 

(0 A breath alcohol concentration shall be converted to an equivalent 
blood alcohol concentration by a calculation based on the relationship: 
the amount of alcohol in 2,100 milliliters of alveolar breath is equivalent 
to the amount of alcohol in 1 millihter of blood. 

(g) Tissue analysis results shall be expressed in terms of a weight 
amount of alcohol in a unit weight of the specimen. 

History 

1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

2. Editorial correction (Register 76, No. 24). 



Article 7. 



Requirements for Breath Alcohol 
Analysis 



§1221. General. 

Breath alcohol analysis shall be performed in accordance with stan- 
dards set forth in this Article. 

NOTE: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: 
Section 436.50, Health and Safety Code. 



History 

1. New Article 7 (Sections 1221, 1221.1 through 122I.5)filed 10-9-70; effective 
thirtieth day thereafter (Register 70, No. 41). 

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

§ 1 221 .1 . Authorized Procedures. 

(a) Breath alcohol analysis shall be performed only with instruments 
and related accessories which meet the standards of performance set 
forth in these regulations. 

(b) Such instruments may be used for the analysis of breath samples 
in places other than licensed forensic alcohol laboratories and by persons 
other than forensic alcohol supervisors, forensic alcohol analysts and fo- 
rensic alcohol analyst trainees only if such places and persons are under 
the direct jurisdiction of a governmental agency or licensed forensic al- 
cohol laboratory. 

(1) Breath alcohol analysis by persons other than forensic alcohol su- 
pervisors, forensic alcohol analysts and forensic alcohol analyst trainees 
shall be restricted to the immediate analysis of breath samples collected 
by direct expiration by the subject into the instrument in which the mea- 
surement of alcohol concentration is performed. 

(2) Except for the requirements of Section 1220.4, such immediate 
analysis shall not be subject to the requirements of Article 6. 

NOTE: Authority cited: SecUons 208 and 436.50, Health and Safety Code. Refer- 
ence: Secfion 436.52, Health and Safety Code. 

History 

1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

2. Repealer of subsecfion (c) filed 12-20-85 as an emergency; effective upon fil- 
ing (Register 85, No. 52). A Certificate of Compliance must be transmitted to 
OAL within 120 days or emergency language will be repealed on 4—21-86. 

3. Certificate of Compliance transmitted to OAL 4-8-86 and filed 5-8-86 (Regis- 
ter 86, No. 19). 

§ 1 221 .2. Standard of Performance. 

(a) Instruments for breath alcohol analysis shall meet the following 
standard: 

( 1 ) The instrument and any related accessories shall be capable of con- 
forming to the "Model Specifications for Evidential Breath Testing De- 
vices" of the National Highway Traffic Safety Administration of the U.S. 
Department of Transportation, which were published in the Federal Reg- 
ister, Vol. 49, No. 242, Pages 48854-48872, December 14, 1984, and are 
hereby adopted and incorporated. 

(b) The ability of instruments and any related accessories to conform 
to the standard of performance set forth in this section shall be tested by 
the U.S. Department of Transportation. 

NOTE: Authority cited: Sections 208 and 436.50, Health and Safety Code. Refer- 
ence: Section 436.52, Health and Safety Code. 

History 

1. Repealer of subsection (b) and relettering of (c), (d), (e), (f) and (g) to (b), (c), 
(d), (e) and (f) filed 4-7-71 ; effective thirtieth day thereafter (Register 71, No. 
15). 

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

3. Amendment filed 12-20-85 as an emergency; effective upon filing (Register 
85, No. 52). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-21-86. 

4. Certificate of Compliance transmitted to OAL 4-8-86 and filed 5-8-86 (Regis- 
ter 86, No. 19). 

§1221.3. Approved Instruments. 

(a) Only such types and models of instruments and related accessories 
as are named in the "Conforming Products List" published in the Federal 
Register by the National Highway Traffic and Safety Administration of 
the U.S. Department of Transportation shall be used for breath alcohol 
analysis in this State. 

NOTE: Authority cited: Sections 208 and 436.50, Health and Safety Code. Refer- 
ence: Section 436.52, Health and Safety Code. 

History 

1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

2. Editorial correction (Register 76, No. 24). 



Page 34 



(4-1-90) 



Title 17 



State Department of Health Services 



§ 1230 



3. Amendment filed 12-20-85 as an emergency; effective upon filing (Register 
S5, No. 52). A Certificate of Compliance must be transmitted to OAL within 1 20 
days or emergency language will be repealed on 4-21-86. 

4. Certificate of Compliance transmitted to OAL 4-8-86 and filed 5-8-86 (Regis- 
ter 86, No. 19). 



§ 1 221 .4. Standards of Procedure. 

(a) Procedures for breath alcohol analysis shall meet the following 
standards: 

( 1 ) For each person tested, breath alcohol analysis shall include analy- 
sis of 2 separate breath samples which result in determinations of blood 
alcohol concentrations which do not differ from each other by more than 
0.02 grams per 100 milliliters. 

(2) The accuracy of instruments shall be determined. 

(A) Such determination of accuracy shall consist, at a minimum, of pe- 
riodic analysis of a reference sample of known alcohol concentration 
within accuracy and precision limits of plus or minus 0.01 grams % of the 
true value; these limits shall be applied to alcohol concentrations from 
0. 1 to 0.30 grams %. The reference sample shall be provided by a foren- 
sic alcohol laboratory. 

1 . Such analysis shall be performed by an operator as defined in Sec- 
tion 1 22 1 .4 (a)(5). and the results shall be used by a forensic alcohol labo- 
ratory to determine if the instrument continues to meet the accuracy set 
forth in Section 1221.4 (a)(2)(A). 

(B) For the purposes of such determinations of accuracy, "periodic" 
means either a period of time not exceeding 1 days or following the test- 
ing of every 150 subjects, whichever comes sooner. 

(3) Breath alcohol analysis shall be performed only with instruments 
for which the operators have received training, such training to include 
at minimum the following schedule of subjects: 

(A) Theory of operation; 

(B) Detailed procedure of operation; 

(C) Practical experience; 

(D) Precautionary checklist; 

(E) Written and/or practical examination. 

(4) Training in the procedures of breath alcohol analysis shall be under 
the supervision of persons who quaUfy as forensic alcohol supervisors, 
forensic alcohol analysts or forensic alcohol analyst trainees in a licensed 
forensic alcohol laboratory. 

(A) After approval as set forth in Section 1218, the forensic alcohol 
laboratory is responsible for the training and qualifying of its instructors. 

(5) An operator shall be a forensic alcohol supervisor, forensic alcohol 
analyst, forensic alcohol analyst trainee or a person who has completed 
successfully the training described under Section 1221.4 (a) (3) and who 
may be called upon to operate a breath testing instrument in the perform- 
ance of his duties. 

(6) Records shall be kept for each instrument to show the frequency 
of determination of accuracy and the identity of the person performing 
the determination of accuracy. 

(A) Records shall be kept for each instrument at a licensed forensic al- 
cohol laboratory showing compliance with this Section. 
NOTE: Authority cited: Section 436.50, Health and Safety Code. Reference: Sec- 
tion 436.50, Health and Safety Code. 

History 

1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

2. Amendment filed 12-20-85 as an emergency; effective upon filing (Register 
85, No. 52). A Certificate of Compliance must be transmitted to OAL within 1 20 
days or emergency language will be repealed on 4-21-86. 

3. Certificate of Compliance including amendment of subsection (a)(2)(A) L 
transmitted to OAL 4-8-86 and filed 5-8-86 (Register 86, No. 19). 



§ 1221.5. Expression of Analytical Results. 

Results of breath alcohol analysis shall be expressed as set forth in Sec- 
tion 1220.4. 



Article 8. Records 

§1222. General. 

Forensic alcohol laboratories and law enforcement agencies shall 
maintain records which clearly represent their activities which are cov- 
ered by these regulations. Such records shall be available for inspection 
by the Department on request. 

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: 
Section 436.50. Health and Safety Code. 

History 

1. New Article 8 (§§ 1222, 1222.1, 1222.2) filed 10-9-70; effective thirtieth day 
thereafter (Register 70, No. 41). 

§ 1222.1. Forensic Alcohol Laboratory Records. 

(a) Each laboratory which is licensed to perform forensic alcohol anal- 
ysis shall keep the following records for a period of at least three years: 

( 1 ) An up-to-date record of persons in its employ who are qualified 
as forensic alcohol supervisors and forensic alcohol analysts; the record 
shall include the qualifications of each such person, including education, 
experience, training and performance in proficiency tests and examina- 
tions; 

(2) A list of persons in its employ who are forensic alcohol analyst 
trainees, the date on which each such person began his training period 
and the number and results of analyses performed during the training pe- 
riod; 

(3) Records of samples analyzed by that laboratory under these regula- 
tions, their results and the identity of persons performing the analyses; 

(4) Records of the quality control program; 

(5) Records of laboratory performance evaluation in alcohol analysis 
as shown by results of proficiency tests; 

(6) Records of such determinations of accuracy of breath testing in- 
struments as a laboratory may perform for law enforcement agencies; 

(7) Records of such training as a laboratory may provide to persons 
who operate breath testing instruments for law enforcement agencies. 

History 
1 . Amendment filed 1 1-24-75; effecfive thirtieth day thereafter (Register 75, No. 
48). 

§ 1222.2. Breath Alcohol Analysis Records. 

(a) Each agency shall keep the following records for breath testing in- 
struments which are under its jurisdiction: 

(1) Records of instrument determinations of accuracy; 

(2) Records of analyses performed, results and identities of the persons 
performing analyses; 

(3) At the location of each instrument, the precautionary checklist to 
be used by operators of the instrument. 

History 

1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No. 
48). 

2. Editorial correcfion (Register 76, No. 24). 



Group 9. HIV Antibody Testing 
Article 1 . Approval of Laboratories 

§ 1230. Approval of Laboratories for Use of HIV Antibody 
Test. 

(a) No person or entity shall perform tests to detect antibodies to HIV 
in California, or on specimens originating in California, unless that per- 
son or entity is 

(1) licensed or certified: 

(A) to engage in the production of biologies in accordance with chap- 
ter 4, division 2 of the Health and SafetyCode, or 

(B) as a clinical laboratory in accordance with chapter 3, division 2 of 
the Business and Professions Code, or 

(C) as a public health laboratory in accordance with chapter 7. part 2, 
division 1 of the Health and Safety Code, or 



Page 35 



Register 91, No. 11; 3-15-91 



§1250 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(D) as a blood bank by the United States Food and Drug Administra- 
tion in accordance with 42 U.S.C., section 262(a), or 

(E) as a clinical laboratory licensed in serology to engage in interstate 
commerce in accordance with the Chnical Laboratory Improvement Act 
of 1967 (CLIA-67). 42 U.S.C. section 263a. and 

(2) Enrolled in a proficiency testing program approved by the Depart- 
ment in accordance with Title 1 7, section 1 05 1 of the California Code of 
Regulations for each HIV screening and confirmatory procedure offered 
by the laboratory. 

(b) An application for approval shall be submitted for each separate 
location where tests are performed using j'orms provided by the Depart- 
ment and providing information as required by the Department. Within 
1 5 days of receipt of an application, the Department shall notify the appli- 
cant in writing that the application is complete or shall specifically identi- 
fy what additional information is required. 

Within 60 days from the receipt of a completed application, the De- 
partment shall notify the applicant that thcapplication is either approved 
or disapproved. 

(c) An approved laboratory shall perform screening for evidence of 
human immunodeficiency virus (HIV) antibody utilizing only Food and 
Drug Administration (USFDA) approved kits. In addition, screening as- 
says shall be performed in strict accordance with a kit's package insert 
and any other manufacturers' instructions or guidelines. 

(d) A specimen shall not be reported as positive on the basis of a 
screening result. Approved laboratories shall perform confirmatory test- 
ing on all specimens tested which give a repeatedly-reactive HIV screen- 
ing result using an additional more specific test prior to reporting the re- 
sult. 

(e) Whenever a confirmatory test gives an indeterminate result, the 
specimen giving such an indeterminate result shall be evaluated further, 
either by additional local testing or by referral to another laboratory. If, 
upon further evaluafion the specimen continues to give an indeterminate 
result, the laboratory shall notify the submitter of the specimen that the 
result is inconclusive. 

(f) An approved laboratory shall maintain records of tests and test re- 
sults in a manner to ensure the patient's confidentiality. 

(g) Approved laboratories which are blood banks or plasma centers 
shall report to the Department at the conclusion of each month and all oth- 
er approved laboratories shall report to the Department at the conclusion 
of each quarter the number and results of the tests performed. 

(h) Approval for performing the tests to detect antibodies to HIV may 
be denied or terminated for failure to comply with the requirements of 
this section or with requirements set forth in law, or for conduct inimical 
to the public health, morals, welfare, or safety of the people of the State 
of California in the maintenance and operation of the facility or services 
for which approval is granted. 

NOTE: Authority cited: Sections 208 and 1603. 1 (h). Health and Safety Code. Ref- 
erence: Section 5, Statutes of 1985, Chapter 23; and Sections 1603.1 and 1632, 
Health and Safety Code. 

History 

1 . New section filed 1-21-86 as an emergency, effecfive upon filing (Register 86, 
No. 6). A certificate of Compliance must be transmitted to OAL within 120 days 
or emergency language will be repealed on 5-21-86. 

2. Change without regulatory effect of group 9 and article 1 heading filed 2-7-86; 
effecfive upon filing (Register 86, No. 6). 

3. Certificate of Compliance as to 1-2 1-86 order including amendment of section 
heading and subsections (b) and (f) transmitted to OAL 5-15-86 and filed 
6-12-86 (Register 86, No. 24). 

4. Amendment filed 1-8-90 as an emergency; operative 1-8-90 (Register 90, No. 
4). A Certificate of Compliance must be transmitted to OAL within 120 days or 
emergency language will be repealed by operation of law on 5-8-90. 

5. Amendment filed 5-1 1-90 as an emergency; operative 5-1 1-90 (Register 90, 
No. 25). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed by operation of law on 9-8-90. 

6. Amendment filed 9-12-90 as an emergency; operative 9-12-90 (Register 90. 
No. 43). A Certificate of Compliance must be transmitted to OAL by 1-10-91 
or the emergency language will be repealed by operation of law on the following 
day. 



7. Certificate of Compliance including amendment transmitted to OAL 1-9-91 
and filed 2-8-91 (Register 91 . No. 1 1 ). 



Chapter 3. Local Health Service 



Subchapter 1. Standards for State Aid for 
Local Health Administration 

(Originally Printed 11-1-47) 



Article 1. Organization 

§1250. Health Officer. 

The health department shall be under the direction of the health officer 
devoting full fime to official dufies and these duties shall constitute his 
primary responsibility and no other acdvities shall interfere with per- 
formance of his official dufies. 

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Sections 454 and 1 130, Health and Safety Code. 

History 
l.NewSecdons 1250 to 1 329, inclusive, filed 10-1^7 as an emergency (Register 

10, No. 1). 

2. Amendment filed 9-24-71 ; effective thirtieth day thereafter (Register 71, No. 
39). 

3. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correcfion 
of Section 1250 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 9-24-7 1 remains in effect uninterrupted (Register 85, No. 
30). 

4. Editorial correcfion of NOTE filed 8-19-85; effecfive thirtieth day thereafter 
(Register 85, No. 34). 

§1251. Office. 

The health department shall maintain and operate a central office and 
headquarters on a full-time basis during the normal work week of the lo- 
cal government. 

NOTE; Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Section 1130, Health and Safety Code. 

History 

1. OAL Nodce of Erroneous Filing filed 7-18-85; purported editorial correcfion 
of Section 1251 filed in error on 7-1-85 is null and void and text as filed with 
Secretai7 of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 
30). 

2. New NOTE filed 8-19-85; effecfive thirtieth day thereafter (Register 85, No. 
34). 

§1252. Clerical Staff. 

There shall be a clerical staff under proper supervision, adequate to 
meet local needs. 

Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Secfion 1130, Health and Safety Code. 

History 

1. OAL Notice of Erroneous Fifing filed 7-18-85; purported editorial correcfion 
of Section 1252 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 
30). 

2. New NOTE filed 8-19-85; effecfive thirtieth day thereafter (Register 85, No. 

34). 

§ 1 253. Public Health Nursing Staff. 

(a) There shall be a public health nursing staff under the supervision 
of a director of public health nursing, and such additional supervisors, 
who are necessary to provide effecfive service. Public health nurses shall 
be qualified and knowledgeable in matters pertaining to health, safety 
and sanitafion within a local health jurisdiction which shall include but 
not be limited to: 

( 1 ) The control and prevention of communicable and chronic disease; 

(2) The promofion of maternal, child and adolescent health; 

(3) The prevenfion of abuse and neglect of children, spouses and elder- 
ly adults within the home environment; 



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§1276 



(4) The case management of California Children Services or handi- 
capped children; 

(5) The assessment and prevention of accidents within the home envi- 
ronment; 

(6) The provision of services for populations at risk; and, 

(b) All members of the public health nursing staff who are employed 
as public health nurses including supervisory personnel shall be certified. 
Note: Authority cited: Section 1130, Health and Safety Code. Reference: Sec- 
tions 600-603, Health and Safety Code. 

History 

1. Amendment filed 6-7-74; effective thirtieth day thereafter (Register 74, No. 
23). 

2. Amendment filed 3-9-87; effective thirtieth day thereafter (Register 87, No. 
11). 

§ 1254. Environmental Health Staff. 

There shall be an adequate staff of Registered Sanitarians under the di- 
rection of a Director of Environmental Health. In addition, the staff shall 
include such other support personnel as are required to carry out the envi- 
ronmental health program. 

NOTE: Authority cited: Sections 208, 1111 and 11 30, Health and Safety Code. 
Reference: Sections 1111 and 1 130, Health and Safety Code. 

History 

1. Amendment filed 5-7-75; effective thirtieth day thereafter (Register 75, No. 
19). 

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Section 1254 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 5-7-75 remains in effect uninterrupted (Register 85, No. 
.30). 

3. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 
34). 

§1255. Public Health Laboratory. 

The principal public health laboratory shall be under the direction of 
a public health laboratory director. A branch public health laboratory 
shall be under the direction of a branch public health laboratory director 
who shall be directly responsible to the director of the principal public 
health laboratory. 

NOTE; Authority cited: Secfions 208, 1111 and 1130, Health and Safety Code. 
Reference: Sections 1000, 1001, 1002, 1111 and 1130, Health and Safety Code. 

History 

1. Amendment filed 5-19-49 (Register 16, No. 4). 

2. Repealer and new secfion filed 1-28-59; effective thirtieth day thereafter (Reg- 
ister 59, No. 3). 

3. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 

34). 

4. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No. 

4). 

5. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Section 1255 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 1-21-77 remains in effect uninterrupted (Register 85, No. 
30). 

6. Editorial correction of NOTE filed 8-19-85; effecfive thirtieth day thereafter 
(Register 85, No. 34). 

§ 1256. Provisional Approval of Health Departments. 

The Director of Health Services, after thorough investigation of geo- 
graphic, transportation, economic, or other conditions, may grant provi- 
sional approval to health departments which serve all of the incorporated, 
as well as the unincorporated, area of the county and which are under the 
direction of a part-time county health officer; provided, however, that 
such counties shall have a population of less than 25,000, as determined 
pursuant to Section 1 101, Chapter 8, Part 2, Division 1 of the Health and 
Safety Code. Such health departments, however, shall meet all standards 
established for local health departments by the Department except Sec- 
tion 1250 of this article. Such provisional approval shall terminate on 
June 30, 1948, but may be renewed annually at the discretion of the Di- 
rector. 

NOTE: Authority cited: Secfions 208, 1111 and 1130, Health and Safety Code. 
Reference: Secfions 1 101, 1 102 and 1 130, Health and Safety Code. 



History 

1. New section filed 1-28-59; effective thirtieth day thereafter (Register 59, No. 
3). 

2. OAL Notice of Erroneous Filing filed 7-18-85: purported editorial correction 
of Secfion 1256 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of Slate on 1-28-59 remains in effect uninterrupted (Reeister 85, No. 
30). 

3. Editorial correcfion filed 8-19-85; effecfive thirtieth day thereafter (Register 
85, No. 34). 



Article 2. Program 

§ 1275. Duties and Functions. 

A local health department, in order to qualify for funds pursuant to Di- 
vision I, Part 2, Chapter 8, of the Health and Safety Code, shall perform 
all of the duties and functions imposed upon it by the Health and Safety 
Code and other statutes of the State of California, and by the rules, regula- 
tions and orders of the Department of Health Services. 
NOTE; Authority cited: Sections 208, 1 111 and 1 130. Health and Safety Code. 
Reference: Sections 1 130 and 1 155. Health and Safety Code. 

History 

1. OAL Nofice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Section 1275 filed in ertor on 7-1-85 is null and void and text as filed with 
Secretary of State on 10-1-47 remains in effect unintertupted (Register 85, No. 
30). 

2. Editorial correction filed 8-19-85; effecfive thirtieth day thereafter (Register 
85, No. 34). 

§1276. Basic Services. 

The health department shall offer at least the following basic services 
to the health jurisdiction which it serves: 

(a) Collection, tabulation and analysis of all public health statistics, in- 
cluding population data, natality, mortality and morbidity records, as 
well as evaluation of service records. 

(b) Health education programs including, but not necessarily limited 
to, staff education, consultation, community organizadon, public infor- 
mation, and individual and group teaching, such programs to be planned 
and coordinated within the department and with schools, public and vol- 
untary agencies, professional societies, and civic groups and individuals. 

(c) Communicable disease control, including availability of adequate 
isolation facilities, the control of the acute communicable diseases, and 
the control of tuberculosis and the venereal diseases, based on provision 
of diagnostic consultative services, epidemiologic investigation and ap- 
propriate preventive measures for the particular communicable disease 
hazards in the community. 

(d) Medical, nursing, educational, and other services to promote ma- 
ternal and child health, planned to provide a comprehensive program to 
meet community needs in these fields. 

(e) Environmental health and sanitation services and programs in ac- 
cordance with an annual plan and program outline as required in Title 1 7, 
Section 1328, and approved by the State Department of Health and the 
applicable services and program standards as specified in the State De- 
partment of Health "Services in a Local Environmental Health and Sani- 
tation Program," September 1976. The required services and programs 
shall be as follows: 

(l)Food. 

(2) Housing and institutions. 

(3) Radiological health in local jurisdictions contracting with the State 
Department of Health to enforce the Radiadon Control Law pursuant to 
Secdon 25600-25654 and Secdons 25800-25876, Health and Safety 
Code. 

(4) Milk and dairy products in local jurisdictions maintaining an ap- 
proved milk inspecdon service pursuant to Secdon 32503, Food and 
Agricultural Code. 

(5) Water oriented recreation. 

(6) Safety. 

(7) Vector control. 

(8) Wastes management. 

(9) Water supply. 



Page 37 



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BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(10) Air sanitation. 

(1 J ) Additional environmentally related services and programs as re- 
quired by the County Board of Supervisors, City Council, or Health Dis- 
trict Board. 

(12) And may include land development and use. 

(f) Laboratory services, provided by an approved public health labora- 
tory in health departments serving a population of 50,000 or more. Such 
laboratories shall provide: 

( 1 ) Services necessary for the various programs of the health depart- 
ment. 

(2) Consultation and reference services to further the development of 
improved procedures and practices in laboratories employing such pro- 
cedures related to the prevention and control of human disease. 

(g) Services in nutrition, including appropriate activities in education 
and consultation for the promotion of positive health, the prevention of 
ill health, and the dietary control of disease. 

(h) Services in chronic disease, which may include case finding, com- 
munity education, consultation, or rehabilitation, for the prevention or 
mitigation of any chronic disease. 

(i) Services directed to the social factors affecting health, and which 
may include community planning, counseling, consultation, education, 
and special studies. 

(j) Services in occupational health to promote the health of employed 
persons and a healthful work environment, including educational, con- 
sultative and other activities appropriate to local needs. Where the popu- 
lation of a health jurisdiction exceeds 500 thousand, the program in occu- 
pational health shall include a planned and organized service with trained 
staff. 

( 1 ) "Services in occupational health" shall mean, as a minimum, a pro- 
gram of industrial sanitation and surveillance of occupational health haz- 
ards to insure that places of employment are maintained in a healthful and 
sanitary condition. For the purpose of this section, "sanitary condition" 
is defined as equivalent to that described in the "Recommended Stan- 
dards of Sanitation in Places of Employment" issued by the California 
State Department of Health Services. Such services shall be provided by 
at least one Occupational Health Sanitarian as defined in Section 1307, 
or any one of the occupational health disciplines in Section 1306, with 
medical, sanitation, and public health nursing support available. 

(2) "Planned and organized service" shall include services in occupa- 
tional health as defined above, and in addition the prevention of work-in- 
duced illness and disability by recognizing, evaluating and preventing 
unhealthful environmental conditions and practices in places of work. 

(3) "Trained staff shall be defined as follows: 

(A) When the health jurisdiction includes a population of 500,000 to 
1 ,000,000, at least 1 , and after July 1 , 1 968, 2 full-time health profession- 
als representing 1 or 2, respectively, of the disciplines listed in part (4) 
hereof shall be employed. 

(B) When health jurisdictions include more than 1 ,000,000 population 
at least 2. and after July 1, 1968, 3 full-time health professionals repre- 
senting 2 or 3, respectively, of the 5 disciplines listed in part (4) hereof 
shall be employed. 

(C) When health jurisdictions include more than 5,000,000 popula- 
tion, at least 10 full-time health professionals including all 5 of the disci- 
plines listed in part (4) hereof shall be employed. 

(4) Occupational health disciplines include: Occupational Health Phy- 
sician; Occupational Health Nursing Consultant; Industrial Hygiene En- 
gineer; Industrial Hygienist (including sanitarians with appropriate train- 
ing); and Industrial Hygiene Chemist as defined in Section 1306. 

(k) Appropriate services in the field of family planning, which may in- 
clude: 

(1) Promotion of availability of program elements such as: 

(A) Assembling knowledge about family planning, attitudes, values, 
and information held by population groups. 

(B) Public and professional educational services about the health 
benefits of family planning and fertility control methods. 



(C) Professional services for sterility correction,fertility control and 
genetic counseling for all segments of the population, making available 
methods acceptable to families of any religious persuasion. 

(D) Evaluation of the adequacy of the community's family planning 
efforts. 

(2) Provision of program elements which are not otherwise likely to 
be made available, including family planning services for those groups 
who cannot reasonably obtain them. 

(1) Public health nursing services to provide for the preventive and 
therapeutic care of the population served. 

NOTE: Authority cited: Sections 208, 1111 and 11 30, Health and Safety Code. 
Reference: Sections 1 11 1, 1 112, 1 113, 11 30, 1 155, 1555.5 and 1 155.6, Health and 
Safety Code. 

History 

1 . Amendment of subsection (j)(l ) filed 6-24-68; effective thirtieth day thereafter 
(Register 68, No. 24). For prior history, see Register 67, No. 50. 

2. Amendment of subsection (f) filed 8-16-71; effective thirtieth day thereafter 
(Register 71, No. 34). 

3. New subsection (1) filed 6-7-74; effective thirtieth day thereafter (Register 74, 

No. 23). 

4. Amendment of subsection (e) filed 12-9-77; effective thirtieth day thereafter 
(Register 77, No. 50). 

5. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial cortection 
of Section 1276 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 12-9-77 remains in effect uninterrupted (Register 85, No. 
30). 

6. Editorial cortection filed 8-19-85; effective thirtieth day thereafter (Reeister 
85, No. 34). 



Article 3. Personnel 

§1300. Health Officer. 

The health officer shall be a graduate of a medical school of good 
standing and repute and shall be eligible for a license to practice medicine 
and surgery in the State of California; provided however that those health 
officers on a full-time basis as of September 19, 1947, shall be consid- 
ered as meeting the requirements of this section. 

NOTE; Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Sections 454 and 1 130, Health and Safety Code. 

History 

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial cortection 
of Section 1300 filed in ertor on 7-1-85 is null and void and text as filed with 
Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 
30). 

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 
34). 

§ 1 301 . Director of Public Health Nursing. 

(a) A director of public health nursing shall be a public health nurse 
who has: 

( 1 ) Completed a baccalaureate program of study in public health nurs- 
ing accredited by the National League for Nursing and has had three 
years of progressively responsible experience in public health nursing or 

(2) A Masters Degree with preparation in Nursing Administration, Su- 
pervision or Consultation from a program accredited by the National 
League for Nursing or the American Public Health Association and at 
least three years of progressively responsible experience in public health 
nursing. 

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Sections 600, 601, 602, 603, 604 and 11 30, Health and Safety Code. 

History 

1. Amendment filed 2-6-51 as an emergency; designated to be effective 3-1-51 
(Register 23, No. 3). 

2. Amendment filed 6-7-74; effective thirtieth day thereafter (Register 74, No. 
23). 

3. OAL Notice of Ertoneous FiUng filed 7-18-85; purported editorial cortection 
of Section 1301 filed in ertor on 7-1-85 is null and void and text as filed with 
Secretary of State on 6-7-74 remains in effect uninterrupted (Register 85, No. 
30). 

4. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 
34). 



Page 38 



(4-1-90) 



Title 17 



State Department of Health Services 



§1306 



§ 1302. Director of the Public Health Laboratory. 

The director of a principal public health laboratory shall be a certified 
Public Health Microbiologist whose qualifications conform with the 
specifications for this position as established by the Department, pur- 
suant to the provisions of the Health and Safety Code. The director shall 
have had four or more years of experience in public health laboratory 
work. The quality, variety and currency of this experience shall be satis- 
factory to the Department. 

NOTK: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Sections 1000, 1002 and 1 130, Health and Safety Code. 

History 

1. New section filed 2-6-51 as an emergency; designated to be effective 3-1-51 
(Register 23, No. 3). 

2. Repealer and new section filed 1-28-59; effective thirtieth day thereafter (Reg- 
ister 59, No. 3). 

3. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No. 
34). 

4. Amendment filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 
4). 

5. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Section 1302 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 1-21-77 remains in effect uninterrupted (Register 85, No. 
30). 

6. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register 
85, No. 34). 

§ 1302.1. Director of a Branch Public Health Laboratory. 

The director of a branch public health laboratory shall be a certified 
Public Health Microbiologist whose qualificafions conform with the 
specifications for this position as established by the Department, pur- 
suant to the provisions of the Health and Safety Code. The director shall 
have had two or more years experience in public health laboratory work. 
The quality, variety and currency of this experience shall be satisfactory 
to the Department. 

NOTE: Authority cited: Sections 208, 1111 and 1130. Health and Safety Code. 
Reference: Secdons 1000, 1002 and 1130, Health and Safety Code. 

History 

1 . New section filed 1-21-77; effective thirtieth day thereafter (Register 77, No. 
4). 

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Section 1 302. 1 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 1-21-77 remains in effect uninterrupted (Register 85, No. 
30). 

3. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register 
85, No. 34). 

§ 1303. Health Educator. 

A health educator shall hold a master's degree with specialization in 
public or community health education awarded upon completion of a 
program of study accredited by the American Public Health Association. 
NOTE; Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Secfion 1 130, Health and Safety Code. 

History 

1 . New section filed 1-28-59; effective thirtieth day thereafter (Register 59, No. 
3). 

2. Amendment filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 
21). 

3. Amendment filed 8-10-70; effective thirtieth day thereafter (Register 70, No. 
33). 

4. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Section 1303 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 8-10-70 remains in effect uninterrupted (Register 85, No. 
30). 

5. Editorial correcfion of NOTE filed 8-19-85; effective thirtieth day thereafter 
(Register 85, No. 34). 

§ 1304. Director of Health Education. 

A director of health education appointed after November 1, 1962 who 
is responsible for the supervision of other professional staff shall have 
had, in addition to the professional training specified above, three or 
more years full-time paid experience in public health education, prefer- 
ably in a local public health department. 

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Secdon 1 130, Health and Safety Code. 



History 

1. New section filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 
21). 

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Section 1304 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 10-1-62 remains in effect unintemjpted (Recister 85, No. 
30). 

3. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter 
(Register 85, No. 34). 

§1305. Public Health Nurse. 

(a) A public health nurse shall be currently licensed to pracfice as a reg- 
istered nurse in California and shall: 

(1) Possess a CaHfomia Public Health Nurse Certificate issued prior 
to March 5, 1954, or a Public Health Nurse Ceruficate issued under the 
provisions of Secfion 4500 et seq: and 

(2) By October 1, 1987 acquire training in the detecfion, prevention, 
reporting requirements and treatment of child abuse and neglect in accor- 
dance with Secfion 4501 of this chapter of working for a local health ju- 
risdicfion on or after January 1, 1981. 

(A) Directors of Public Health Nursing as defined in Section 1301 
shall have the responsibility for veiifying that all members of their Public 
Health Nursing Staff who have received Public Health Nurse Certificates 
prior to October 1, 1987, have received training which satisfies the re- 
quirement in Section 4501(a)(4). 

(B) The Department of Health Services shall have the responsibility 
for verifying that all nurses who receive a Public Health Nurse Certificate 
after October 1, 1987 have received training which satisfies the require- 
ments in Secfion 4501(a)(4). 

Note: Authority cited: Sections 208, 600, 602 and 1 1 30, Health and Safety Code. 
Reference: Section 600, 602, 605 and 1 130, Health and Safety Code. 

History 

1. New secdon filed 10-1-62; effecdve thirtieth day thereafter (Register 62, No. 
21). 

2. Amendment filed 8-16-71; effecdve thirtieth day thereafter (Register 71, No. 

34). 

3. Repealer and new secdon filed 6-7-74; effective thirtieth day thereafter (Regis- 
ter 74, No. 23). 

4. Amendment filed 3-9-87; effecdve thirtieth day thereafter (Register 87, No. 
11). 

§ 1306. Occupational Health Trained Staff. 

Qualificafions for each discipline included in the definition of trained 
staff shall conform to the following specifications: 

(a) Occupational Health Physician. M.D. degree and license to prac- 
fice medicine in California, and either: 

(1) a master's degree in public health or occupational medicine and 
two years' experience in the full-fime practice of occupational medicine, 
or 

(2) four years' experience in the full-time practice of occupational 
medicine, at least one year of which shall have been in a public health 
program. 

(b) Occupafional Health Nursing Consultant. Baccalaureate degree 
and possession of a vafid license as a registered nurse and a valid Califor- 
nia Public Health Nurse certificate, and, either: 

(1 ) a master' s degree in pubUc health and two years' experience in the 
full-fime pracfice of occupafional health nursing, or 

(2) four years' experience m the full-time pracfice of occupational 
health nursing, and two years in a generalized public health nursing pro- 
gram. 

(c) Industrial Hygiene Engineer. Baccalaureate degree in engineering, 
and either: 

(1) a master's degree in pubHc health or industrial hygiene and two 
years' experience in the full-time practice of industrial hygiene engi- 
neering, or 

(2) four years' experience in the full-time practice of industrial hy- 
giene engineering, at least one year of which shall have been in a public 
health program. 



Page 39 



Register 98, No. 42; 10- 16-98 



§1307 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(d) Industrial Hygienist. Baccalaureate degree with major in a physical 
or biological science, and, either: 

(1) a master's degree in public health or industrial hygiene and two 
years' experience in the fill-time practice of industrial hygiene, or 

(2) four years' experience in the full-time practice of industrial hy- 
giene, at least one year of which shall have been in a public health pro- 
gram, or 

(3) registration as a sanitarian in California with four years' experience 
in a local health department, three years of which shall have been in the 
full-time practice of industrial hygiene. 

(e) Industrial Hygiene Chemist. Baccalaureate degree with major in 
chemistry or biochemistry, and, either: 

( 1) a master's degree in chemistry, biochemistry, or a related field of 
environmental chemistry and two years' experience as a professional 
chemist doing increasingly complex analytical procedures, or 

(2) four years' experience as a professional chemist doing increasingly 
complex analytical procedures. 

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Section 1130, Health and Safety Code. 

History 

1 . New section filed 1 2-1 5-67; effective thirtieth day thereafter. (Register 67, No. 
50). 

2. Amendment of subsection (d) filed 6-24—68; effective thirtieth day thereafter 
(Register 68, No. 24). 

3. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Section 1306 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 6-24—68 remains in effect uninterrupted (Register 85, No. 
30). 

4. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter 
(Register 85, No. 34). 

§ 1307. Occupational Health Sanitarian. 

(a) Qualifications for an Occupational Health Sanitarian shall conform 
to the following specifications: 

(1) Registration as a sanitarian in California; 

(2) Three years' full-time experience in environmental sanitation; 

(3) One year of experience in an occupational health program of a local 
health department under direct supervision of an Industrial Hygiene En- 
gineer or Industrial Hygienist as defined in Section 1306, or satisfactory 
completion of a two-week intensive training course in the recognition of 
occupational health hazards conducted by the California State Depart- 
ment of Public Health, or the equivalent of such a course conducted by 
an institution acceptable to the Department. 

(b) An Occupational Health Sanitarian with two years' full-time expe- 
rience in that classification may qualify as an Industrial Hygienist for the 
purposes of Section 1 276(j)(4) of this Code by completing two additional 
years of full-time experience in industrial hygiene under the direct super- 
vision of an Industrial Hygiene Engineer or Industrial Hygienist quali- 
fied under Section 1306 above. 

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Secfions519, 1111 and 1130, Health and Safety Code. 

History 

1. New secfion filed 6-24-68; effecfive thirtieth day thereafter (Register 68, No. 
24). 

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Secfion 1307 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 6-24-68 remains in effect uninterrupted (Register 85, No. 
30). 

3. Editorial correcdon of NOTE filed 8-19-85: effecfive thirtieth day thereafter 
(Register 85, No. 34). 

§ 1308. Director of Environmental Health. 

A director of Environmental Health shall hold a valid certificate of 
registration as a Sanitarian in the State of California and shall have had 
three or more years' experience in an environmental health agency (a 
Master's Degree in Public Health, Health Science, Public Administra- 
tion, or related field may be substituted for one year of the required expe- 
rience). 

Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Sections 1130 and 1155, Health and Safety Code. 



History 

1 . New section filed 5-7-75; effective thirtieth day thereafter (Register 75, No. 
19). 

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial coiTcction 
of Section 1308 filed in enor on 7-1-85 is null and void and text as filed with 
Secretary of State on .5-7-75 remains in effect uninterrupted (Register 85, No. 
30). 

3. Editorial correction of NOTE filed 8-19-85; effecfive thirtieth day thereafter 
(Register 85, No. 34). 



Article 4. Finance 

§1325. Use of Funds. 

Funds available to local health departments under Chapter 8, Part 2, 
Division 1 of the Health and Safety Code may be expended for personnel, 
including but not limited to new or additional personnel and adjustments 
of salaries of existing personnel, maintenance and operation, equipment, 
and for capital expenditures. The funds may be used only to augment lo- 
cal appropriations provided for public health purposes, through the local 
public health department, including those functions listed in Article 2, 
but not including any of the following: 

(a) Medical, hospital and therapeutic care of physically handicapped 
children. 

(b) Maintenance of hospitals (including emergency hospitals and first 
aid stations), sanatoria and homes. 

(c) Garbage and refuse collection and disposal, and sewage disposal. 

(d) Street cleaning. 

(e) Inspection of building construction. 

(f) Inspection of plumbing. 

(g) Maintenance of dog or animal pounds, 
(h) Inspection of cemeteries. 

Note: Authority cited: Sections 100275, 100295 and 100950, Health and Safety 
Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code. 

History 

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Secfion 1325 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 
30). 

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 
34). 

3. Change without regulatory effect amending Note filed 10-13-98 pursuant to 
section 100, title 1, California Code of Regulations (Register 98, No. 42). 

§ 1326. Restrictions on Matching Funds. 

For matching purposes as specified in Section 101255 of the Health 
and Safety Code, local health departments shall not include funds appro- 
priated for functions listed under subsections (a) to (h), inclusive of Sec- 
tion 1325 above. 

Note; Authority cited: Sections 100275, 100295 and 100950, Health and Safety 
Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code. 

History 

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction 
of Section 1326 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on lC^-1-47 remains in effect uninterrupted (Register 85, No. 
30). 

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 

34) 

3. Change without regulatory effect amending section and Note filed 10-13-98 
pursuant to section 1 00, title 1 , Cahfornia Code of Regulations (Register 98, No. 

42). 

§ 1327. Deposit and Expenditure of Funds. 

The governing body of each local health department shall set up a spe- 
cial fund or account as approved by the State Department and all pay- 
ments received from the State by the governing body shall be deposited 
in that fund or account. No money shall be expended from such fund or 
account except for public health purposes in accordance with Division 
1 , Part 2, Chapter 8, of the Health and Safety Code, and the rules and reg- 
ulations adopted by the State Department of Health Services pursuant 
thereto. 

NOTE: Authority cited: Sections 100275, 100295 and 100950, Health and Safety 
Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code. 



Page 40 



Register 98, No. 42; 10-16- 



Title 17 



State Department of Health Services 



§ 1363 



History 

1. Amendment filed 7-2-64; effective thirtieth day thereafter (Register 64, No. 
14). 

2. OAL Notice of EiToneous Filing filed 7-18-85; purported editorial conection 
of Section 1 327 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 7-2-64 remains in effect uninten-upted (Register 85, No. 
30). 

3. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85. No. 
34). 

4. Change without regulatory effect amending Notf; filed 10-13-98 pursuant to 
section 100. title 1, California Code of Regulations (Register 98, No. 42). 

§ 1328. Budget and Program. 

Local health departments shall submit a budget each year, showing a 
total plan for the expenditure of public health funds during the year, to- 
gether with an outline of the program contemplated. The appropriation 
made in support of such budget shall also be reported. 
NOTI-:: Authority cited; Sections 100275, 100295 and 100950, Health and Safety 
Code. Reference: Sections 100295, 101250 and 101255. Health and Safety Code. 

History 

1. OAL Nofice of Erroneous Fihng filed 7-18-85; purported editorial correction 
of Section 1328 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 10-1-47 remains in effect uninteiTupted (Register 85, No. 
30). 

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No. 
34.) 

3. Change without regulatory effect amending NOTii filed 10-13-98 pursuant to 
section 100, title 1, California Code of Regulafions (Register 98, No. 42). 

§1329. Reports. 

Local health departments shall report their expenditures, and shall 
submit reports of services and operations, upon forms provided for that 
purpose, at such times as the State Department of Health Services may 
require. 

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. 
Reference: Sections II 30, 1 153 and 1 154. Health and Safety Code. 

History 

1. OAL Notice of Erroneous Fihng filed 7-18-85; purported editorial correction 
of Section 1329 filed in error on 7-1-85 is null and void and text as filed with 
Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No. 
30). 

2. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register 
85, No. 34). 



Note: Authority cited: Sections 208, 1 11 1 and 1 155.6, Health and Safety Code. 
Reference: Section 1 155.5, Health and Safety Code. 

History 
1. New NOTE filed 5-8-84 (Register 84, No. 19). 



Subchapter 2. Standards for State Aid for 
Comprehensive Environmental Agencies 



Article 1. Definitions 

§ 1351. Comprehensive Environmental Agency. 

"Comprehensive Environmental Agency" means an agency responsi- 
ble to the board of supervisors which has been assigned the total function 
of providing environmental health and sanitation services and programs 
and other related environmental management functions which the board 
of supervisors may choose to delegate to the agency. 
NOTE: Authority cited: Sections 208, 1 11 1 and 1 155.6, Health and Safety Code. 
Reference: Section 1 155.5, Health and Safety Code. 

History 

1. New Subchapter 2 (Sections 1351-1375, not consecufive) filed 12-9-77; effec- 
tive thirtieth day thereafter (Register 77, No. 50). 

2. Editorial con-ection of NOTE filed 5-8-84 (Register 84, No. 19). 

§ 1353. Environmental Health and Sanitation Services and 
Programs. 

"Environmental Health and Sanitation Services and Programs" means 
those agency provided services and programs which are required by the 
Director of the State Department of Health to meet local environmental 
health and sanitation needs. The term shall include additional environ- 
mentally related services and programs for which responsibility has been 
delegated to the agency by the county Board of Supervisors or Health 
District Board. 



Article 2. Agency Personnel and Facilities 

§ 1355. Director of Environmental Health. 

(a) There shall be a full-time Director of Environmental Health who 
shall be responsible for the administration of environmental health and 
sanitation services and programs. 

(b) The Director shall meet the following minimum qualifications: 

( 1 ) Possession of a valid certificate of registration as a sanitarian in the 
State of California. 

(2) Three or more years' experience in an environmental health 
agency. A Master's Degree in Public Health, Health Science, Public Ad- 
ministration, or a related field may be substituted for one year of the re- 
quired experience. 

Note: Authority cited: Sections 208, 1 1 1 1 and 1 155.6, Health and Safety Code. 
Reference: Secuons 1 155.5 and 1 155.6, Health and Safety Code. 

History 
1 . New NOTE filed 5-8-84 (Register 84, No. 19). 

§1357. Environmental Health staff. 

There shall be an adequate staff of Registered Sanitarians meeting the 
qualifications established by the State Department of Health pursuant to 
provisions of the Health and Safety Code and other support personnel 
necessary to implement agency services and programs. Staffing units 
shall be equal to or greater than those levels provided by the environmen- 
tal health unit of the health department prior to the transfer. 
Note: Authority cited: Sections 208, 1 11 1 and 1 L55.6, Health and Safety Code. 
Reference: Sections 1 155.5 and 1 155.6. Health and Safety Code. 

History 
1. New NOTE filed 5-8-84 (Register 84, No. 19). 

§1359. Clerical staff. 

There shall be sufficient, properly supervised clerical staff to meet 
agency needs. Staffing levels shall be equal to or greater than those levels 
provided by the environmental health unit of the health department prior 
to the transfer. 

Note: Authority cited: Secfions 208, 1 1 1 1 and 1 155.6. Health and Safety Code. 
Reference: Secfions 1 155.5 and 1 155.6, Health and Safety Code. 

History 
1. New NOTE filed 5-8-84 (Register 84, No. 19). 

§1361. Office Facilities. 

There shall be provided publicly accessible office faciUties which 
shall be in operation full time during the normal county government work 
week. 

Note: Authority cited: Sections 208, 11 1 1 and 1 155.6, Health and Safety Code. 
Reference: Secfions 1 155.5 and 1155.6, Health and Safety Code. 

History 
1. New NOTE filed 5-8-84 (Register 84, No. 19). 



Article 3. Organization 

§ 1 363. Conditions of Transfer. 

(a) Prior to transferring environmental health and sanitation services 
and programs from a local health department to an agency, the following 
shall be met: 

(1) The county board of supervisors or health district board shall au- 
thorize the total environmental health and sanitation services and pro- 
grams to be transferred and maintained as a single organizational unit. 

(2) The Director of the State Department of Health shall give written 
approval for the transfer. 

(3) The proposed agency shall have a State Department of Health ap- 
proved annual program plan. 



Page 41 



Register 98, No. 42; 10-16-98 



§1365 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



NOTH; Authority cited: Sections 208, 1111 anil 1 153.6, Health and Safety Code. 
Reference: Sections 1 155.5 and 1 155.6, Heahli and Safety Code. 

History 
1. New NOTE fded 5-8-84 (Register 84, No. 19). 

§ 1 365. Powers and Duties of the County Health Officer. 

The county health officer shall retain powers, duties, and responsibili- 
ties relating to the protection of public health as set forth in Section 452 
of the Health and Safety Code. 

NOTE: Authority cited: Sections 208, 1111 and 1 155.6, Health and Safety Code. 
Reference: Sections 452, 1 155.5 and 1 155.6, Health and Safety Code. 

History 
1 . New NOTE filed 5-8-84 (Register 84, No. 19). 

§ 1 367. Powers and Duties of the District Health Officer. 

The district health officer shall retain powers, duties, and responsibili- 
ties relating to the protection of public health as set forth in Division 1, 
Part 2, Chapter 6 (commencing with Section 880) of the Health and Safe- 
ty Code. 

NOTE: Authority cited: Sections 208, 1 II 1 and 1 155.6, Health and Safety Code. 
Reference: Division 1, Part 2, Chapter 6 (commencing with Section 880) (Pur- 
suant to the Savings Clause in Statutes 1959, Chapter 380, Page 2305, Section 3, 
as amended by Statutes 1961, Chapter 1362, Page 3137, Section 1; Statutes 1968, 
Chapter 468, Page 1099, Section 1) and Sections 1 155.5 and 1 155.6, Heahh and 
Safety Code. 

History 
1. New NOTE filed 5-8-84 (Register 84, No. 19). 

§ 1369. Powers and Duties of the Director of 
Environmental Health. 

(a) The Director of Environmental Health shall have powers and duties 
relating to environmental health and sanitation services and programs. 

(b) The powers and duties shall be clearly delineated in writing and 
shall provide for well-defined, direct lines of communication with the 
county or district health officer to assure coordination of pubhc health 
programs and environmental health and sanitation services and pro- 
grams. 

(c) These regulations shall not be deemed to diminish or impede any 
additional powers and duties of the Director of Environmental Health 
specified by statute, rule, regulation, resolution or order, or which may 
have been delegated to him by the county or district health officer. 
NOTE: Authority cited: Sections 208, 1111 and 1 155.6, Health and Safety Code. 
Reference: Sections 11 55.5 and 11 55.6, Health and Safety Code. 

History 

I. New NOTE filed 5-8-84 (Register 84, No. 19). 



Article 4. Program 

§1371. Basic Program. 

(a) Environmental health and sanitation services and programs shall 
be offered in accordance with an annual program plan approved by the 
State Department of Health and the applicable services and program 
standards an specified in the State Department of Health "Services in a 
Local Environmental Health and Sanitation Program," September 1976. 
The required services and programs shall be as follows: 

(l)Food. 

(2) Housing and institutions. 

(3) Radiological health in local jurisdictions contracting with the State 
Department of Health to enforce the Radiation Control Law pursuant to 
Sections 25600-25654 and Sections 25800-25876, Health and Safety 
Code. 

(4) Land development and uses. 

(5) Milk and dairy products in local jurisdictions maintaining an ap- 
proved milk inspection service pursuant to Section 32503, Food and 
Agricultural Code. 

(6) Occupational health. 

(7) Water oriented recreation. 

(8) Safety. 

(9) Vector control. 



(10) Wastes management. 

(11) Water supply. 

(12) Additional environmentally related services and programs as re- 
quired by the County Board of Supervisors, City Council, or Health Dis- 
trict Board. 

(13) Air sanitation. 

NOTE: Authority cited: Sections 208, 1 1 1 1 and 1 155.6, Health and Safety Code. 
Reference: Sections 1 155.5 and 11 55.6, Health and Safety Code. 

History 
1. New NOTE filed 5-8-84 (Register 84, No. 19). 

§ 1373. Annual Program Plans. 

(a) Each county or district shall submit to the State Department of 
Health, annually for approval, program plans in each of the categories 
specified in Section 1371. 

(b) The annual program plans shall contain information pertaining to 
comiTiunity needs, authority, goals, objectives, activities, personnel, and 
program evaluation as may be required by the State Department of 
Health. 

Note: Authority cited: Secdons 208, 1 1 1 1 and 1 155.6, Health and Safety Code. 
Reference: Secfions 1 155.5 and 1 155.6, Health and Safety Code. 

History 
I. New NOTE filed 5-8-84 (Register 84, No. 19). 

§1375. State Financial Aid. 

County or district eligibility for funds pursuant to Division 1, Part 2, 
Chapter 8 (commencing with Section 1 100) of the Health and Safety 
Code shall be contingent upon fulfillment by the agency of all environ- 
mental health and sanitation requirements imposed upon county or dis- 
trict health departments by state statutes, rules, regulations and orders, 
and by local ordinances. 

NOTE: Authority cited: Secfions 208, 1 11 1 and 11 55.6, Health and Safety Code. 
Reference: Sections 1 155.5 and 1 155.6, Health and Safety Code. 

History 
1. New NOTE filed 5-8-84 (Register 84, No. 19). 



Subchapter 3. Standards for Maintaining 
County Health Services 



Article 1. Application 



§ 1 401 . Application of Subchapter. 

Subchapter 3 shall apply to local jurisdictions that elect to apply for 
State funds under the provisions of Part 4.5 of Division 9 of the Welfare 
and Institutions Code. 

NOTE: Authority cited: Section 16712, Welfare and InstituUons Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16702, 
Welfare and Institutions Code. 

History 

1 . New Subchapter 3 (Secfions 1401-1463, not consecufive) filed 10-18-78 as an 
emergency; effective upon filing (Register 78, No. 42). 

2. Certificate of Compliance filed 2-6-79 (Register 79, No. 6). 

3. Repealer of Subchapter 3 (Sections 1401-1463, not consecutive) and new Sub- 
chapter 3 (Secfions 1401-1497, not consecufive) filed 8-29-80 as an emergen- 
cy; designated effective 8-29-80 (Register 80, No. 35). A Certificate of Com- 
pliance must be transmitted to OAL within 120 days or emergency language 
will be repealed on 12-29-80. 

4. Certificate of Compliance transmitted to OAL 12-5-80 and filed 1-14-81 
(Register 81, No. 3). 

5. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

6. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

§ 1403. Section Headings. 

Section headings contained herein shall not be deemed to govern, lim- 
it, or modify the provisions of any section. 

NOTE: Authority cited: Secfion 16712, Welfare and Institutions Code. Reference: 
Secfion 16712, Welfare and Institufions Code. 



Page 42 



Register 98, No. 42; 10-16-9 



Title 17 



State Department of Health Services 



§ 1420.1 



Article 2. Definitions 

§1405. Addendum. 

NOTH: Authority cited: Section 16812, Welfare and Institutions Code. Reference: 

Section 16990, Welfare and Institutions Code. 

History 

1. Change without regulatory effect repealing section and amending NoTi; filed 
1 0-13-98 pursuant to section 1 00, title 1 , California Code of Regulations (Reg- 
ister 98, No. 42). 

§1407. Agreement, 

"Agreement" means the Standard Agreement for County Health Ser- 
vices entered into and signed by the governing body of each local juris- 
diction and the Director of the State Department of Health Services 
which specifies the conditions under which monies shall be transferred 
to each local jurisdiction from the County Health Services Fund pursuant 
to Part 4.5 of Division 9 of the Welfare and Institutions Code. 
Note: Authority cited: Section 1 67 1 2. Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 
16704(b), Welfare and Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

§1409. Allocation. 

NOTE: Authority cited: Section 16712, Welfare and Institutions Code. Reference 
cited: Sections 16702 and 16704, Welfare and Institutions Code. 

History 

1. Renumbering and amendment of Section 1409 to Secfion 1418 filed 12-31-82 
as an emergency; effective upon filing (Register 83, No. 2). A Certificate of 
Compliance must be transmitted to OAL within 120 days or emergency lan- 
guage will be repealed on 4-30-83. 

2. Certificate of Compliance transmitted to OAL 4-29-83 and filed 6-9-83 (Reg- 
ister 83, No. 24). 

§ 1411. Annual Local Jurisdiction Budget. 

"Annual Local Jurisdiction Budget" means the official local jurisdic- 
tion budget adopted each year by the governing body of the local jurisdic- 
tion. 

NOTE: Authority cited: Secfion 16812, Welfare and Insfitufions Code; and Stat- 
utes of 1982, Chapter 1594, Secfion 87(c). Reference: Secfion 16990, Welfare and 
Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effecfive upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correcdon of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect amending Note filed 10-13-98 pursuant to 
section 100, Ufie 1, California Code of Regulations (Register 98, No. 42). 

§1411.1. Benefits Chart. 

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Secfion 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Secfion 
87(c). Reference: Section 16709, Welfare and Insfitufions Code. 

History 

1. New section filed 12-31-82 as an emergency; effecfive upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of Note transmitted to 
OAL 4^29-83 and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending section head- 
ing and Note filed 9-7-2005 pursuant to section 100, title 1, California Code 
of Regulations (Register 2005, No. 36). 

§1413. Budget. 

NOTE: Authority cited: Secfion 16712, Welfare and Institutions Code. Reference 
cited: Section 16700, Welfare and Insfitufions Code. 

History 
1. Renumbering and amendment of Section 1413 to Section 1430.3 filed 
12-31-82 as an emergency; effecfive upon filing (Register 83, No. 2). A Certifi- 



cate of Compliance must be transmitted to OAL within 1 20 days or emergency 
language will be repealed on 4-30-83. 

2. Certificate of Compliance transmitted to OAL 4-29-83 and filed 6-9-83 (Reg- 
ister 83. No. 24). 

§ 1 41 5. City Health Services. 

"City health services" means public health services, outpatient health 
services, and inpatient health services provided directly by a city or fi- 
nanced or purchased by a city through grants, contracts, or agreements, 
but not including services provided pursuant to Division 5, Welfare and 
Institutions Code, or Division 10.5, Health and Safety Code. 
NOTE: Authority cited: Section 167 1 2, Welfare and Institutions Code. Reference: 
Section 16701(c), Welfare and Institutions Code. 

§ 1417. County Health Services. 

"County health services" means public health services, outpatient 
health services, and inpatient health services provided directly by a local 
jurisdiction or financed or purchased by a local jurisdiction through 
grants, contracts, or agreements but not including services provided: 

(1) Pursuant to Division 5, Welfare and Institutions Code. 

(2) Pursuant to Division 10.5, Health and Safety Code. 

(3) In Fiscal Year 1977-78 which are not part of the reported net 
county costs for Fiscal Year 1 977-78. 

NOTE; Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 
16701(a), Welfare and Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

§ 1418. County Health Services Allocation. 

"County Health Services Allocation" means monies disbursed from 
the County Health Services Fund established pursuant to subdivision (a) 
of Section 16703, Welfare and Institutions Code, in an amount specified 
in the Standard Agreement for County Health Services entered into and 
signed by duly authorized local jurisdiction officials and the Director of 
Health Services. The "County Health Services Allocation" consists of an 
amount based on county population, in the case of a county, and may in- 
clude an amount based on net costs budgeted by a local jurisdiction for 
the provision of health services. 

NOTE: Authority cited: Secfion 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Secfion 87(c). Reference: Sections 16700, 16702 and 
16704, Welfare and Insfitufions Code. 

History 

1 . Renumbering and amendment of Secfion 1409 to Section 1418 filed 12-31-82 
as an emergency; effecfive upon filing (Register 83, No. 2). A Certificate of 
Compliance must be transmitted to OAL within 120 days or emergency lan- 
guage will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correcfion transmitted to OAL 
4-29-83 and filed 6-9-83 (Register 83, No. 24). 

§1419. County Health Services Fund. 

"County Health Services Fund" means the fund created by Section 
16703, subdivision (a). Welfare and Institutions Code, for deposit of 
monies appropriated for distribution to the local jurisdictions pursuant to 
Part 4.5 of Division 9 of the Welfare and Institutions Code. 
NOTE: Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Secfion 87(c). Reference: Sections 16700 and 16703, 
Welfare and Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

§ 1420.1. County Medical Services Program. 

NOTE: Authority cited: Secfion 10725, Welfare and Institutions Code; Section 
100275, Health and Safety Code; and StaUites of 1982, Chapter 1594, Section 
87(c). Reference: Secfion 16709, Welfare and Institutions Code. 



Page 43 



Register 2005, No. 36; 9-9-2005 



§ 1420.2 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial conection of Note transmitted to 
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatoiy effect repealing section and amending NOTi-; filed 
9-7-2005 pursuant to section 100, title 1 , California Code of Resulations (Reg- 
ister 2005, No. 36). 

§ 1420.2. County Medical Services Program Account. 

NOTH: Authority cited: Section 10725, Welfare and Insututions Code; Section 
100275. Heahh and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Section 16709(d), Welfare and Institutions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending Note filed 
9-7-2005 pursuant to section 100, fitle 1, California Code of Regulations (Reg- 
ister 2005, No. 36). 

§ 1420.3. County Medical Services Program Contract. 

Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Secfion 
87(c). Reference: Section 16709, Welfare and Institutions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20 
days or einergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correcUon of Note transmitted to 
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending Note filed 
9-7-2005 pursuant to secfion 100, title \, California Code of Regulations (Reg- 
ister 2005, No. 36). 

§ 1420.4. Declaration of Intent to Enter into Contract. 

NOTE: Authority cited: Secfion 10725, Welfare and Institutions Code; Section 
100275. Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Section 16709, Welfare and Insututions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correcdon of Note transmitted to 
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending Note filed 
9-7-2005 pursuant to section 100, title I, California Code of Regulations (Reg- 
ister 2005, No. 36). 

§ 1420.5. County Medical Services Program Reserve 
Account. 

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; and Section 
100275, Health and Safety Code. Reference: Section 16709(g), Welfare and Insti- 
tutions Code. 

History 

1 . New section filed 4-4-86 effective thirtieth day thereafter (Register 86, No. 1 4). 

2. Change without regulatory effect repealing section and amending Note filed 
9-7-2005 pursuant to secfion 100, fitle 1, California Code of Regulations (Reg- 
ister 2005, No. 36). 

§1421. Department. 

"Department" means the State Department of Health Services. 
NOTE: Authority cited: Section 16712, Welfare and Insfitutions Code. Reference 
cited: Secfion 16702, Welfare and Insfitufions Code. 

§1422. Director. 

"Director" means the Director of the State Department of Health Ser- 
vices. 

NOTE; Authority cited: Section 16712, Welfare and Institutions Code. Reference 
cited: Section 16700, Welfare and Institutions Code. 

§ 1 422.1 . Eligible Contract County, 

"EHgible Contract County" means a county which has requested the 
transfer of funding pursuant to Section 11 57.5 of the Health and Safety 
Code. 



NOTE; Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1 982. Chapter 1594, Section 87(c). Reference: Section 16704, Welfare and 
Institutions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No.^24). 

§ 1422.3. Eligibility Manual. 

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Section 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Section 16709, Welfare and Institutions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of Note transmitted to 
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending Note filed 
9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Reg- 
ister 2005, No. 36). 

§1423. Expenditures. 

"Expenditures" means funds budgeted or expended to support health 
program operations and includes: 

( 1 ) Health services supplied or provided for through purchase or con- 
tract. 

(2) Salaries and employee benefits. 

(3) Operation and maintenance costs. 

(4) Depreciation of facilities owned by a local jurisdiction. 

(5) Administrative costs. 

(6) Federal Revenue Sharing Funds budgeted or expended for these 

health activities. 

NOTE; Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16708, Welfare and 
Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial cortection of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

§ 1425. Fixed Assets, Fixtures, Structures and 
Improvements. 

NOTE: Authority cited: Section 16812, Welfare and Institutions Code. Reference: 

Section 16708, Welfare and Institutions Code. 

History 

1 . Change without regulatory effect repealing section and amending Note filed 
10-13-98 pursuant to section 100, title 1 , California Code of Regulations (Reg- 
ister 98, No. 42). 

§ 1427. Inpatient/Outpatient Services. 

"Inpatient/outpatient services" means those medical care services pro- 
vided directly by a local jurisdiction or purchased or provided through 
contracts with other providers which may include but not be limited to: 

(1) General acute inpatient hospital services. 

(2) Outpatient services administered by hospital staff, non-hospital 
based county clinics, and community clinics funded by a local jurisdic- 
tion. 

(3) Skilled nursing facilities. 

(4) Licensed home health agencies. 

(5) Rehabilitation facility services. 

(6) Inpatient/outpatient services for criminal justice inmates. 

(7) Ambulance and related emergency services. 

NOTE: Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 
16701(a), Welfare and Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 



Page 44 



Register 2005, No. 36; 9-9-2005 



Title 17 



State Department of Health Services 



§ 1437 



§1428. Local Jurisdiction. 

"Local Jurisdiction" means a county, the San Joaquin Local Health 
District, a city which has not transferred to the county enforcement au- 
thority of applicable health statutes and regulations, or a city which pro- 
vides public health services pursuant to a contract with a county through 
an organized health department recognized by the Department. 
NOTf': Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1 594, Section 87(c). Reference: Section 16700, Welfare and 
Institutions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No.^24). 

§ 1429. Maximum Allocation. 

NOTK: Authority cited: Section 16812, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16705, Welfare and 
Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending Note filed 
10-13-98 pursuant to section 100, title 1, California Code of Regulations (Reg- 
ister 98, No. 42). 



§1430. May, Shall, Should. 

"May" means permissible. "Shall" means mandatory. "Should" 
means desirable. 

NOTE: Authority cited: Section 16712, Welfare and Institutions Code. Reference: 
Section 16712, Welfare and Insfitutions Code. 

§ 1 430.1 . Medically Indigent Services Account. 

NOTE: Authority cited: Section 16812, Welfare and Institufions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803(b), Welfare 
and Institutions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending Note filed 
10-13-98 pursuant to section 100, title 1, Cahfomia Code of Regulations (Reg- 
ister 98, No. 42). 



§ 1430.2. Medically Indigent Services Allocation. 

NOTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803, Welfare and 
Institutions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending Note filed 
1 0- 1 3-98 pursuant to section 1 00, title 1 , California Code of Regulations (Reg- 
ister 98, No. 42). 



§ 1 430.3. Multi-Year Budget. 

NoTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16990, Welfare and 
Institutions Code. 

History 
1. Renumbering and amendment of Section 1413 to Section 1430.3 filed 
1 2-3 1 -82 as an emergency; effective upon filing (Register 83, No. 2). A Certifi- 



cate of Compliance must be transmitted to OAL within 1 20 days or emergency 
language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial conection of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83. No. 24). 

3. Change without regulatory effect repealing section and amending NoTi-; filed 
10- 13-98 pursuant to secfion 100, title 1, California Code of Regulations (Reg- 
ister 98, No. 42). 



§ 1430.4. Multi-Year Plan. 

"Multi-Year Plan" means the County Health Services three-year plan 
which describes proposed county health services in a format specified by 
the Department and submitted by a local jurisdiction pursuant to Part 4.5 
of Division 9 of the Welfare and Institutions Code. 
NOTE: Authority cited: Secfion 16712, Welfare and In.stitutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16700, Welfare and 
Institutions Code. 

History 

1. Renumbering and amendment of Section 1433 to Section 1430.4 filed 
12-31-82 as an emergency; effective upon filing (Register 83, No. 2). A Certifi- 
cate of Compliance must be transmitted to OAL within 120 days or emergency 
language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial coirection of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

§ 1 431 . Net City Costs for Health Services. 

NOTE: Authority cited: Section 1681 2, Welfare and Institutions Code. Reference: 

Section 16801(e), Welfare and Institutions Code. 

History 

1 . Change without regulatory effect repealing section and amending Note filed 
10-13-98 pursuant to secfion 100, fitle 1, California Code of Reguladons (Reg- 
ister 98, No. 42). 

§ 1432. Net County Costs for Health Services. 

"Net county costs for health services" means expenditures for county 

health services less revenues received for county health services plus 

Federal Revenue Sharing funds budgeted or expended for county health 

services. 

NOTE: Authority cited: Secfion 16712, Welfare and Institutions Code. Reference: 
Section 16701(b), Welfare and Insfitufions Code. 

§ 1433. Plan. 

NOTE: Authority cited: Section 16712, Welfare and Insfitutions Code. Reference: 

Secfion 16700, Welfare and Institutions Code. 

History 

1. Renumbering and amendment of Section 1433 to Section 1430.4 filed 
1 2-3 1-82 as an emergency; effective upon filing (Register 83, No. 2). A Certifi- 
cate of Compliance must be transmitted to OAL within 1 20 days or emergency 
language will be repealed on 4-30-83. 

§1435. Public Health Services. 

"Public health services" means those health promotion, surveillance, 
and disease prevention services designed to protect the health of the pub- 
lic, population groups, and individuals. 

NOTE: Authority cited: Section 1 6812, Welfare and Institufions Code. Reference: 
Secfion 16801, Welfare and Insfitutions Code. 

History 
1. Change without regulatory effect amending Noti-; filed 10-13-98 pursuant to 

section 100, fitie 1, California Code of Regulations (Register 98, No. 42). 

§ 1 437. Reported Net County Costs for Fiscal Year 
1977-78. 

"Reported net county costs for Fiscal Year 1977-78" means those net 
county costs for health services for Fiscal Year 1977-78 which were 
originally reported to the Department pursuant to Section 20 of Chapter 
292 of the Statutes of 1978 or amended pursuant to County Health Ser- 
vices Bulletin #2-1 979. These costs are those exact amounts listed below 
by county except that the amount listed for Alameda County does not in- 
clude the net costs for Berkeley and the amount listed for San Joaquin 
County does not include the net costs for the San Joaquin Local Health 
District: 



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§1439 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Alameda 


$22,649,584 


C)range 


$21,552,624 


Alpine 


$23,704 


Placer 


$812,227 


Amador 


$491,123 


Plumas 


$115,890 


Butte 


$1,179,463 


Riverside 


$10,248,905 


Calaveras 


$35,861 


Sacramento 


$9,646,438 


Colusa 


$273,457 


San Benito 


$80,536 


Contra Costa 


$11,924,448 


San Bernardino 


$7,920,785 


Del Norte 


$106,435 


San Diego 


$10,797,538 


El Dorado 


$1,015,867 


San Francisco 


$40,124,175 


Fresno 


$11,853,293 


San .loaquin 


$3,006,398 


Glenn 


$121,505 


San Luis Obispo 


$1,889,127 


Humboldt 


$1,238,729 


San Mateo 


$8,280,966 


Imperial 


$1,035,813 


Santa Barbara 


$4,647,590 


Inyo 


$593,006 


Santa Clara 


$16,715,698 


Kern 


$8,830,127 


Santa Cruz 


$2,592,658 


Kings 


$718,199 


Shasta 


$563,682 


Lake 


$64,719 


Sierra 


$15,916 


Lassen 


$401,705 


Siskiyou 


$285,207 


Los Angeles 


$177,838,404 


Solano 


$1,006,584 


Madera 


$311,721 


Sonoma 


$1,439,658 


Marin 


$1,760,674 


Stanislaus 


$4,384,380 


Mariposa 


$24,291 


Sutter 


$999,607 


Mendocino 


$547,607 


Tehama 


$474,072 


Merced 


$1,301,322 


Trinity 


$318,281 


Modoc 


$164,312 


Tulare 


$2,317,423 


Mono 


$424,737 


Tuolumne 


$328,064 


Monterey 


$4,200,837 


Ventura 


$5,803,840 


Napa 


$820,398 


Yolo 


$1,419,400 


Nevada 


$171,556 


Yuba 


$334,214 


NOTE: Authority cited: Section 16812. 


, Welfare and Institutions Code. Reference: 


Section 16990, 


Welfare and Institutions Code. 





History 

1. Change without regulatory effect amending Note filed 10-13-98 pursuant to 
section 100, title 1, California Code of Regulations (Register 98, No. 42). 

§ 1439. Revenues. 

"Revenues" means income budgeted or received for health services 
from fees, fines, grants, subventions, and/or monetary aid from govern- 
ment agencies but excluding property taxes, Federal Revenue Sharing, 
and monies provided pursuant to Part 4.5 of Division 9 of the Welfare and 
Institutions Code. 

NOTE: Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1 594, Section 87(c). Reference: Section 16700, Welfare and 
Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Comphance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No. 24). 

§1440. "Update." 

NOTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1 594, Section 87(c). Reference: Section 16936, Welfare and 
Institutions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending Note filed 
1 0- 1 3-98 pursuant to section 1 00, dtle 1 , Calilomia Code of Regulations (Reg- 
ister 98, No. 42). 



Article 3. County Health Services 
Multi-Year Plan and Budget 

§ 1445. Multi-Year Plan and Budget Submission. 

(a) Beginning in 1983, and each third subsequent year thereafter, the 
governing body of each county, the Cities of Berkeley, Long Beach, and 
Pasadena, and the San Joaquin Local Health District shall adopt and shall 
submit a Multi-Year Plan and Budget to the Director in the form and in 
accordance with procedures specified in this Article on or before Sep- 
tember 15. 



(b) Beginning in 1984, and each year thereafter, the governing body 
of each county, the Cities of Berkeley, Long Beach, and Pasadena, and 
the San Joaquin Local Health District shall adopt and shall submit an up- 
date of its adopted Multi-Year Plan and Budget to the Director in the 
form and in accordance with procedures specified in this Article on or be- 
fore September 15. 

(c) Copies of the Multi-Year Plan and Budget and Update shall be sub- 
mitted to the appropriate area health planning agency simultaneously to 
submission to the Department. 

(d) Submission of a Multi-Year Plan and Budget or Update shall not: 

( 1 ) Relieve any county of its indigent health care obligation under Sec- 
tion 17000, Welfare and Institutions Code. 

(2) Restrict the ability of the State or any interested person or persons 
to obtain any judicial relief to which there is entitlement. NOTE: Author- 
ity cited: Section 16712, Welfare and Institutions Code; and Statutes of 
1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 
1671 1, Welfare and Institutions Code. 

History 

1. Amendment of subsection (b) filed 5-21-81; effective thirtieth day thereafter 
(Register 81, No. 21). 

2. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

3. Certificate of Compliance including editorial correction transmitted to OAL 
4-29-83 and filed 6-9-83 (Register 83, No. 24). 

4. Amendment of Article 3 heading and Section 1445 filed 4-4-86; effective thir- 
tieth day thereafter (Register 86, No. 14). 

§ 1451. Multi-Year Plan and Budget and Update Content. 

(a) The Multi-Year Plan and Budget submitted by each local jurisdic- 
tion shall contain but not be limited to a: 

(1) Narrative section which provides a description of public health, 
and inpatient and outpatient services be provided or contracted for by the 
local jurisdiction. 

(2) Budget section which details proposed expenditures, revenues and 
net county costs for county health services. 

(3) Certification section containing signatures necessary for the for- 
mal transfer of State and/or Federal monies to the local jurisdiction pur- 
suant to the Multi-Year Plan and Budget. 

(b) The Multi-Year Plan and Budget shall include only health pro- 
grams, services, and administrative support that are part of the reported 
net county costs for Fiscal Year 1 977-78 and may include any new health 
programs which have been instituted since Fiscal Year 1977-78. 

(c) Health programs and associated costs which existed during Fiscal 
Year 1977-78 and which are not part of the reported net county costs for 
Fiscal Year 1977-78 shall be excluded from the Multi-Year Plan and 
Budget, but may be in the Addendum identified in (d). 

(d) The Multi-Year Plan and Budget may contain an Addendum 
which includes narrative descriptions and estimated expenditures, reve- 
nues, and net county costs for health services, exclusive of mental health, 
alcohol, and drug abuse treatment, not reported in the Plan and Budget. 

(e) In those counties, except the County of Alameda, where the gov- 
erning body of a city has not transferred to the county enforcement au- 
thority of applicable public health statutes and regulations or where pub- 
lic health services are provided b a city pursuant to a contract with a 
county, such a county shall, in the Multi-Year Plan and Budget, Update, 
and Agreement, provide for continuation and funding of such services. 

(f) The Multi-Year Plan and Budget shall include only fiscal informa- 
tion which is consistent with the regulations on capital expenditures, de- 
preciation, and administrative overhead as listed below: 

(1) Capital expenditures for local jurisdiction structures and fixtures, 
and improvements to local jurisdiction structures and fixtures shall not 
be considered allowable costs. 

(2) Depreciation for local jurisdiction structures and fixtures, and im- 
provements to local jurisdiction structures and fixtures shall be an allow- 
able expense for purposes of applying for monies pursuant to 1466. De- 
preciation also shall be an allowable expense for purposes of applying for 
monies pursuant to 1465(a) only if the: 



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Title 17 



State Department of Health Services 



§1466 



(A) Reported net county costs for Fiscal Year 1977-78 included de- 
preciation expenses for such local jurisdiction staictures and fixtures, or 
improvements to local jurisdiction structures and fixtures; or. 

(B) Reported net county costs for Fiscal Year 1977-78 included capi- 
tal expenditures for such local jurisdiction structures and fixtures, or im- 
provements to local jurisdiction structures and fixtures; or, 

(C) Capital expense was incurred after June 30, 1978 and was for an 
allowable expense as determined by Department guidelines and regula- 
tions. 

(3) Expenditures for fixed assets involving inpatient or outpatient 
health services for persons certified eligible pursuant to Section 17000 
of the Welfare and Institutions Code shall be depreciated and all other ex- 
penditures for fixed assets may be either expensed or depreciated, but not 
both. 

(4) Administrative overhead shall be listed as a single line item or dis- 
tributed across all programs, but not both. 

(5) The Multi-Year Plan and Budget and Update shall include the Cost 
Allocation Summary presented annually to the State Controller's Office 
for the determination of indirect costs for Federal grants and contracts. 

(g) The Multi-Year Plan and Budget and Update shall include infor- 
mation pertaining to medical services provided to indigent county resi- 
dents. Specifically the Plan and Budget and Update shall include but not 
be limited to: 

( 1 ) The eligibility criteria the county uses to determine whether a per- 
son is certified as eUgible for health services under Section 17000 of the 
Welfare and Institutions Code. 

(2) A description of the county's eligibility process used to determine 
whether a person is eligible for services under Section 17000 of the Wel- 
fare and Institutions Code. 

(3) A description of how county residents are notified or informed of 
the availability of county financed services pursuant to Section 17000 of 
the Welfare and Institutions Code. 

(4) A listing of services or benefits which are provided. 

(5) A listing of the location of services and how the county ensures rea- 
sonable accessibility of such services. 

(6) A description of the county's fee collection policies, fee schedules, 
procedures and expected revenues for persons covered by Section 17000 
of the Welfare and Institutions Code. 

(7) An estimate of the Section 1 7000 target population size and an esti- 
mate of the number of persons who will use the services/benefits. 

(8) A projection of the estimated costs of serving the medically indi- 
gent population under Section 17000 of the Welfare and Institutions 
Code. 

(h) The annual Update of the Multi-Year Plan and Budget submitted 
by the local jurisdiction shall contain but not be limited to: 

( 1 ) The requirements specified in subdivisions (a) through (g), and any 
other instructions, forms, and guidelines developed by the Department 
pertaining to the annual Update. 

(2) The Update shall not duplicate any of the material in the Multi- 
Year Plan and Budget. 

(3) The Update also shall serve as a progress report evaluating what 
has been accomplished over the past year and shall provide specific ti- 
me-limited measurable objectives in relation to each of the elements in 
the Multi-Year Plan and Budget during the apphcable fiscal year. 
NoTE: Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700, 16709, 
16710 and 1671 1, Welfare and Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No. 24). 

3. Amendment of Subsections (a)(1), (a)(2), (f)(5) and (g) filed 4-4-86; effective 
thirtieth day thereafter (Register 86, No. 14). 



§ 1457. Plan and Budget Review. 

(a) The Department shall review the County Health Services Multi- 
Year Plan and Budget or Update submitted by each local jurisdiction to 
ensure as a minimum that the Multi-Year Plan and Budget or Update: 

(1) Have been submitted in accordance with the procedures specified 
by the Director. 

(2) Are in the format and cover the content specified by the Director. 

(3) Contain the necessary signatures and certifications as specified by 
the Director. 

(4) Contain budgeted financial data by budget unit as specified in the 
Annual County Budget and are presented in the format specified by the 
Department. 

(5) Include copies of revenue and appropriations pages from the An- 
nual County Budget for each budget unit listed pursuant to (4). Interim 
documentation may be submitted until an official Annual County Budget 
has been printed. 

(6) Are in conformance with: 

(A) Uniform accounting standards and procedures. 

(B) Fiscal policies stated in these regulations. 

(C) Guidelines issued by the Department. 

(b) Based on the review of the Multi-Year Plan and Budget or Update, 
the Department may require a local jurisdiction to submit additional data 
or information in a format specified by the Department. 

( 1 ) The data or information shall be requested to augment an incom- 
plete or inaccurate submission. 

(2) Any local jurisdiction which does not comply with the request shall 
be considered as not having submitted a Multi-Year Plan and Budget or 
Update in conformance with Department guidelines and regulations and 
shall not receive per capita monies from the County Health Services 
Fund. 

(c) All fiscal information submitted as part of the Multi-Year Budget 
or Update shall be verifiable and shall be subject to State audit. 
NOTE: Authority cited: Section 16712. Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16704, 
Welfare and Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effecfive upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

Article 4. Allocations, Agreement, 

Disbursement, Reporting and Recoupment 

Procedures 

§ 1465. County Health Services Allocation. 

NOTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16704 and 16705, 
Welfare and Institutions Code. 

History 

1. Amendment of subsection (b)(3) filed 5-21-81: effective thirtieth day thereaf- 
ter (Register 81, No. 21). 

2. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

3. Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No. 24). 

4. Change without regulatory effect repealing section and amending NoTi-. filed 
10-13-98 pursuant to section 100, title 1, California Code of Regulations (Reg- 
ister 98, No. 42). 

§ 1466. Medically Indigent Services Allocation. 

(a) The Department shall compute each county's Medically Indigent 
Services Allocation in accordance with Subdivision (d) of Section 1 6703 
of the Welfare and Institutions Code. 

(b) A county may apply for all or a portion of its total allocation pur- 
suant to 1473(c). If the County chooses to apply for these funds, it shall 



Page 47 



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§1467 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



be bound by conditions and limitations contained in paragraph ( 1) of sub- 
division (c) of Section 16704 of the Welfare and Institutions Code on the 
use of such funds. 

NOTE: Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982. Chapter 1594, Section 87(c). Reference: Sections 16703(b), 
16704(c) and 16709(a), Welfare and Institutions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2), A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial coiTection of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 



§ 1467. Medically Indigent Services Application. 

(a) In order to apply for the Medically Indigent Services Allocation, 
a county shall submit to the Department an Application adopted by the 
County Board of Supervisors prior to the disbursement of funds from the 
Medically Indigent Services Account. The Application shall be in a form 
and in accordance with procedures specified by the Director and shall 
contain but not be limited to the following: 

( 1 ) Unless a county has contracted with the Department pursuant to 
Article 6, an assurance by the County that it will incur no less in net costs 
of county funds for county health services in any fiscal year than the 
amount required to obtain the maximum allocation as specified in 
1465(a). 

(2) An assurance by the county that funds allocated pursuant to 1466 
shall be expended only for health services included in Sections 14132 
and 14021 of the Welfare and Institutions Code for persons certified eli- 
gible pursuant to Section 17000 of the Welfare and Institutions Code. A 
county shall not be bound by utilization control provisions which are spe- 
cified within Sections 14132 and 14021. 

(3) An assurance by the county that funds allocated pursuant to 1466 
shall not be expended for costs of services specified in county Short- 
Doyle plans which are in excess of the 125 percent limitation specified 
in Section 5705.1 of the Welfare and Institutions Code. 

Note: Authority cited: Section 16712, Welfare and Institution Code; and Statutes 
of 1982, Chapter 1594, Section 8(c). Reference: Sections 16704(c) and 16706, 
Welfare and Institutions Code. 

History 
1. New section filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 
14). 

§ 1469. Agreement. 

(a) Upon completion of the Departmental review of a local jurisdic- 
tion's Multi-Year Plan and Budget or Update, the Department shall issue 
an Agreement for review and signature by appropriate officials repre- 
senting the local jurisdicfion. The agreement shall include, as appropri- 
ate, but shall not be limited to: 

(1) The total funds to be allocated to the county based on population 
as specified in 1465(a)(1). 

(2) The total funds to be allocated to the county based on budgeted al- 
lowable expenditures, revenues, and net costs as specified in 1465(a)(2). 

(3) The total funds to be allocated to an Eligible Contract County sole- 
ly for public health services as specified in 1465(a)(3). 

(4) The total funds to be allocated to the City of Berkeley as specified 
in 1465 (a)(5). 

(5) The total funds to be allocated to the San Joaquin Local Health Dis- 
trict solely for pubUc health services as specified in 1465(a)(6). 

(6) The net costs of local jurisdiction funds for health services that 
must be incurred by the local jurisdiction in order to receive the total allo- 
cation specified in 1465(a). 

(7) The sharing ratio of State funds as specified in (2), (3), (4) and (5) 
to the local jurisdiction funds as specified in (6). The sharing ratios shall 
not exceed those specified in 1465(h), as applicable. 

(8) An assurance by the local jurisdiction that it agrees to expend local 
jurisdiction funds for net county costs for county health services in the 
amounts specified in 1465(c), (d), (e), and (f), as applicable. 



(9) An assurance by the local jurisdiction that the health services pro- 
vided by the Agreement will be in general accordance with the local juris- 
diction' s Multi-Year Plan and Budget or Update. 

( 1 0) An assurance by the local jurisdiction that monies provided by the 
State under the terms of this Agreement will be used to finance health ser- 
vices as described in the Multi-Year Plan and Budget or Update and for 
no other purpose. 

(1 1 ) An assurance by the local jurisdiction that sufficient records, files 
and documentation will be maintained for State review concerning pro- 
gram activity and expenditures made under this Agreement and will be 
accessible for a period of at least four years from the expiration of this 
Agreement, or in the event of a State audit, until the audit has been re- 
solved. 

(12) An assurance by the local jurisdiction that access will be provided 
during normal working hours to authorize representatives of the Depart- 
ment and of other State agencies to all records, files, and documentation 
related to the Agreement. 

(13) An assurance by the local jurisdiction that reports will be pro- 
vided as required by the Department. 

(b) The Agreement shall also include provisions pertaining to medi- 
cally indigent services funds received pursuant to 1466. The provisions 
shall include but not be limited to: 

( 1 ) The total funds to be allocated to the county based on the allocation 
specified in 1466. 

(2) The net costs for health services that must be incurred by the county 
in order to receive the allocafion specified in 1466. 

(3) An assurance by the county that it will incur no less in net costs of 
county funds for county health services in any fiscal year than the amount 
required to obtain the maximum allocafion specified in 1465. 

(4) An assurance by the county that funds allocated pursuant to 1466 
shall be expended only for health services included in Secdons 14132 
and 14021 of the Welfare and Insfitutions Code for persons certified eli- 
gible pursuant to Secfion 17000 of the Welfare and Insfitudons Code. A 
county shall not be bound by utilization control provisions which are spe- 
cified within Secdons 14132 and 14021. 

(5) An assurance by the county that funds allocated pursuant to 1466 
shall not be expended for costs of services specified in county Short- 
Doyle plans which are in excess of the 125 percent limitadon specified 
in Secdon 5705.1 of the Welfare and Insdtutions Code. 

(6) The total funds to be provided by the State as specified in (a) and 
in (b)( 1 ) above, under the terms of the Agreement. 

(c) The Agreement shall constitute a contractual obligation. 

(d) A local jurisdicdon that has not submitted a signed Agreement to 
the Department by the end of a current fiscal year shall be subject to re- 
coupment of any funds disbursed pursuant to (b)(1). 

(e) A local jurisdicdon that does not conform with any or all of the 
terms of the Agreement may be subject to recoupment of funds disbursed 
to that local jurisdicdon. 

Note: Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16704 and 16706, 
Welfare and Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction transmitted to OAL 
4-29-83 and filed 6-9-83 (Register 83, No. 24). 

§1473. Disbursement. 

Note: Authority cited: Section 16812, Welfare and Institufions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803, Welfare and 
Institutions Code. 

History 

1 . Amendment of subsection (a)(2) filed 5-21-81 ; effective thirtieth day thereafter 
(Register 81, No. 21). 

2. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

3. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 



Page 48 



Register 2005, No. 36; 9-9-2005 



Title 17 



State Department of Health Services 



§1477 



4. Amendment filed 4-4-86; effective thirtieth day thereafter (Register 86, No. 

14). 

5. Change without regulatory effect repealing section and amending Note filed 
10-1 3-98 pursuant to section 100, fitle 1, California Code of Reaufations (Reg- 
ister 98, No. 42). 

§1475. Reports. 

(a) For Fiscal Year 1979-80 and annually thereafter, each local juris- 
diction shall submit to the Department a report of estimated actual expen- 
ditures, revenues, and net county costs for services provided in accor- 
dance with the Multi-Year Plan and Budget or Update. 

( 1 ) The report shall be submitted in a form and in accordance with pro- 
cedures specified by the Department. 

(2) The report shall be due on November 15 in the year following the 
fiscal year for which data s being reported. 

(b) For Fiscal Year 1979-80 and annually thereafter, each local juris- 
diction shall submit to the Department a report of actual expenditures, 
revenues and net county costs for services provided in accordance with 
the Multi-Year Plan and Budget or Update. 

( 1 ) The report shall be submitted in accordance with the format and 
procedures as specified by the Department. 

(2) The report shall be due on November 15 in the second year follow- 
ing the fiscal year for which data is being reported. 

(c) Beginning on November 15, 198 hand annually thereafter each lo- 
cal jurisdiction shall prepare and submit to the Department a report de- 
scribing health services provided by the local jurisdiction pursuant to 
Part 5 (commencing with SecUon 17000) of Division 9 of the Welfare 
and Institutions Code. 

(1) The report shall be submitted in accordance with the procedures 
and Umetable as established by the Department. 

(2) The report shall include but not be limited to information covering 
the following: 

(A) Eligibility standards 

(B) Services provided 

(C) Resources utilized 

(D) Fees collected 

(E) Target population size 

(F) Costs 

(d) The Director shall withhold part or all payment of County Health 
Services Funds to a local jurisdiction, unless the reports specified in (a) 
through (c) have been received by the Department. 

Note: Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16706 and 16716, 
Welfare and Institutions Code. 

History 

1. New section filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance includina editorial correction transmitted to OAL 
4-29-83 and filed 6-9-83 (Register'83, No. 24). 

§1477. Recoupment. 

(a) For Fiscal Year 1979-80 and annually thereafter, the Department 
shall review the report specified in 1475(a), which shall serve as the ini- 
fial basis for the recovery of funds not expended in accordance with the 
Agreement described in 1469. 

( 1 ) The Department: 

(A) Shall determine whether or not the county has reported only net 
costs specifically allowed pursuant to Department guidelines and regula- 
tions. 

(B) May disallow reported costs that are inaccurate or are not allow- 
able costs for county health services or for health services provided to 
persons eligible pursuant to Section 1 7000 of the Welfare and Institu- 
fions Code. 

(2) The Department shall notify the local jurisdicfion in wrifing of its 
determinations and allowances made pursuant to (1). 

(3) Notification shall be sent to the local jurisdiction's governing 
body, Auditor-Controller, Administrative Officer, and the Health 



Agency Director, Health Officer, and Hospital Administrator, as applica- 
ble. 

(4) The notification for the fiscal year shall list: 

(A) Aggregate net county costs specified in the Agreement. 

(B) Estimated actual net county costs as reported pursuant to 1475(a). 

(C) The difference between the two ainounts. 

(5) If the estimated actual net county costs are less than the aggregate 
net county costs specified in the Agreement, the notificafion shall declare 
the Department's intent to do one or a combination of the following in 
order to recoup the State porfion of the funds specified in (4)(C): 

(A) Adjust subsequent payments to the local jurisdiction from the 
County Health Services Fund. 

(B) Negotiate a repayment plan for the local jurisdiction. 

(C) Withhold the appropriate amount from other State funds payable 
to the local jurisdiction. 

(b) For Fiscal Year 1979-80 and annually thereafter, the Department 
shall review the report specified in 1475(b) which shall serve as the final 
basis for recoupment of funds not expended in accordance with the 
Agreement described in 1469, unless the report is modified by actual au- 
dit findings officially adopted by the State. 

( 1 ) The Department: 

(A) Shall determine whether or not the local jurisdiction has reported 
only net costs specifically allowed pursuant to Department guidelines 
and regulations. 

(B) May disallow reported costs that are inaccurate or are not allow- 
able after verifying the information with the local jurisdiction and notify- 
ing them of the proposed disallowance. 

(2) The Department shall notify the local jurisdiction in writing of its 
determinations and disallowances made pursuant to ( 1 ) and of any differ- 
ence between the actual net county costs reported pursuant to 1475(b) 
and the estimated actual net county costs reported pursuant to 1475(a). 

(3) Notification shall be sent to the local jurisdiction's governing 
body, Auditor-Controller, Administrative Officer, and the Health 
Agency Director, Health Officer, and Hospital Administrator, as applica- 
ble. 

(4) The notification for the fiscal year shall list the: 

(A) Actual net county costs as reported pursuant to 1475(b). 

(B) Estimated actual net county costs as reported pursuant to 1475(a). 

(C) Difference between the two amounts. 

(5) If the actual net county costs are less than the estimated actual net 
county costs the notification shall declare the Department's intent to do 
one or a combination of the following in order to recoup the State portion 
of the funds specified in (4)(c): 

(A) Adjust subsequent payments to the local jurisdiction from the 
County Health Services Fund. 

(B) Negotiate a repayment plan for the local jurisdiction. 

(C) Withhold the appropriate amount from other State funds payable 
to the local jurisdiction. 

(c) The governing body of the local jurisdiction shall have twenty-one 
(21) working days, following receipt of notification pursuant to (a)(2) or 
(b)(2) to appeal the Department's decision. The appeal shall be in accor- 
dance with the format and procedures specified by the Department. 

(d) Tlie Department may adjust the monthly payments made to a 
county pursuant to an Agreement as specified in 1469(b) if the county 
fails to expend such funds as specified in the Agreement. 

(e) The Department shall recover any unexpended funds disbursed to 
county as specified in 1473(b) for medically indigent services in accor- 
dance with the procedures specified in the Agreement. 

(f) The Department shall recover any funds not expended pursuant to 
1469(b) in accordance with the procedures specified in the Agreement. 
NOTE; Authority cited: Section 16712, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16706, Welfare and 
Institutions Code. 

History 
I. Amendment of subsections (d)(B) and (e) filed 5-21-81 ; effective thirtieth day 
thereafter (Register 81, No. 21). 



Page 49 



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§1481 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



2. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20 
days or emergency language will be repealed on 4-30-83. 

3. Certificate of Compliance including editorial correction transmitted to OAL 
4-29-83 and filed 6-9-83 (Register 83, No. 24). 

§ 1481. Special Needs and Priorities. 

NOTE: Authority cited: Section 16812, Welfare and histitutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16707, Welfare and 
Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No. 24). 

3. Amendment filed 4^1-86; effective thirtieth day thereafter (Register 86, No. 

14). 

4. Change without regulatory effect repealing section and amending Note filed 
1 0-1 3-98 pursuant to section 1 00, fitle 1 , California Code of Regulations (Reg- 
ister 98, No. 42). 



Article 5. Public Hearing Procedures 

§1485. Purpose. 

Note: Authority cited: Section 16812, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Secdon 87(c). Reference: SecUons 16705 and 
16705.5, Welfare and Institutions Code. 

History 
\. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 

83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 

days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No.'24). 

3. Change without regulatory effect repealing section and amending NOTE filed 
10-13-98 pursuant to secdon 100, title 1, California Code of Reguladons (Reg- 
ister 98, No. 42). 

§1486. Conditions. 

NOTE: Authority cited: Secdon 16812, Welfare and Insdtutions Code; and Stat- 
utes of 1982, Chapter 1594, Secdon 87(c). Reference: Secdons 16705 and 
16705.5, Welfare and Institudons Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effecdve upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending Note filed 
10-13-98 pursuant to secdon 100, title 1, California Code of Reguladons (Reg- 
ister 98, No. 42). 

§1487. Scheduling. 

NOTE: Authority cited: Secdon 16812, Welfare and Institudons Code; and Stat- 
utes of 1982, Chapter 1594, Secdon 87(c). Reference: Secdons 16705 and 
16705.5, Welfare and Institutions Code. 

History 

1. Amendment filed 12-31-82 as an emergency; effecdve upon filing (Register 
83, No. 2). A Certificate of Compliance must be d-ansraitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

2. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

3. Change without regulatory effect repealing section and amending Note filed 
10-13-98 pursuant to section 100, title 1, California Code of Regulations (Reg- 
ister 98, No. 42). 

§1489. Notification. 

NOTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Secdon 87(c). Reference: Secdons 16705 and 
16705.5, Welfare and Institutions Code. 

History 

1. Amendment of subsections (a)(1) and (a)(2) filed 5-21-81; effecdve thirtieth 
day thereafter (Register 81, No. 21). 

2. Amendment filed 12-31-82 as an emergency; effecdve upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 



3. Certificate of Compliance including editorial conection of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

4. Change without regulatory effect repealing section and amending Note filed 
10-13-98 pursuant to section 100, title 1, California Code of Regulations (Reg- 
ister 98, No. 42). 

§1491. Conduct. 

NOTE; Authority cited: Section 16812, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Secdons 16705 and 
16705.5, Welfare and Institutions Code. 

History 

1. Amendment of subsections (b) and (d) filed 5-21-81; effective thirtieth day 
thereafter (Register 81, No. 21). 

2. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

3. Certificate of Compliance includine editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

4. Change without regulatory effect repealing secdon and amending Note filed 
10-13-98 pursuant to section 100, tide 1 , California Code of Regulations (Reg- 
ister 98, No. 42). 

§1493. Findings. 

NOTE: Authority cited: Section 16812. Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Secdon 87(c). Reference: Secdon 16705, Welfai-e and 
Institutions Code. 

History 

1. Amendment of subsection (a) filed 5-21-81; effective thirtieth day thereafter 
(Register 81, No. 21). 

2. Amendment filed 12-31-82 as an emergency; effecdve upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

3. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

4. Change without regulatory effect repealing section and amending Note filed 
1 0-1 3-98 pursuant to section 1 00, title 1 , California Code of Regulations (Reg- 
ister 98, No. 42). 

§1495. Transmittal. 

NOTE: Authority cited: Section 16812, Welfare and Institudons Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Secdons 16705 and 
16705.5, Welfare and Institudons Code. 

History 

1. Amendment of subsection (a) filed 5-21-81; effective thirtieth day thereafter 
(Register 81, No. 21). 

2. Amendment filed 12-31-82 as an emergency; effective upon fihng (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

3. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

4. Change without regulatory effect repealing section and amending Note filed 
10-13-98 pursuant to secdon 100, tide 1, California Code of Regulations (Reg- 
ister 98, No. 42). 

§1497. Determinations. 

NOTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat- 
utes of 1982, Chapter 1594, Section 87(c). Reference: Secdons 16705 and 
16705.5, Welfare and Institudons Code. 

History 

1. Amendment of subsections (b) and (c) and new subsection (f) filed 5-21-81; 
effective thirtieth day thereafter (Register 81, No. 21). 

2. Amendment filed 12-31-82 as an emergency; effective upon filing (Register 
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120 
days or emergency language will be repealed on 4-30-83. 

3. Certificate of Compliance including editorial correction of NOTE transmitted 
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

4. Change without regulatory effect repealing section and amending Note filed 
1 0- 1 3-98 pursuant to section 1 00, title 1 , California Code of Regulations (Reg- 
ister 98, No. 42). 



Article 6. 



County Medical Services 
Program 



§ 1498. County Medical Services Program. 

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Section 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Secdon 16709, Welfare and Institutions Code. 



Page 50 



Register 2005, No. 36; 9-9-2005 



Title 17 



State Department of Health Services 



§1501 



History 

1. New Article 6 (Sections 1498-1498.9) filed 12-31-82 as an emergency; effec- 
tive upon filing (Register 83, No. 2). A Certificate of Compliance iriust be trans- 
mitted to OAL within 120 days or emergency lanauase will be repealed on 
4-30-83. 

2. Certificate of Compliance including amendments and editorial con-ections 
transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83. No. 24). 

3. Amendment of subsection (f) filed 4^-86; effective thirtieth day thereafter 
(Register 86, No. 14). 

4. Change without regulatory effect repealing section and ainending Note filed 
9-7-2005 pursuant to section 100. fitle 1 , California Code of Regulations (Reg- 
ister 2005, No. 36). 

§ 1 498.1 . Declaration of intent to Contract. 

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Section 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Sections 16703 and 16709, Welfare and Institutions Code. 

History 

1 . Certificate of Compliance including editorial conection of NoTi-: transmitted to 
OAL 4-29-83 and filed 6-9-83 (Register 83. No. 24). 

2. Amendment of subsecUons (a) and (c) filed 4-4-86; effective thirtieth day 
thereafter (Register 86, No. 14). 

3. Change without regulatory effect repealing section and amending Note filed 
9-7-2005 pursuant to section 100, title I, California Code of Regulations (Reg- 
ister 2005, No. 36). 

§ 1498.2. Small County Advisory Committee. 

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Secdon 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Section 16709, Welfare and Institutions Code. 

History 

1 . Certificate of Compliance including editorial correction of Note transmitted to 
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

2. Change without regulatory effect repealing section and amending Note filed 
9-7-2005 pursuant to section 100. title 1, California Code of Regulations (Reg- 
ister 2005, No. 36). 

§1498.3. Contract. 

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Section 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Sections 16704 and 16709, Welfare and Insfitutions Code. 

History 

1. Certificate of Compliance including amendment of subsection (a)(1) and Note 
transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

2. Amendment of subsections (c), (d) and (e) filed 4-4-86; effective thirtieth day 
thereafter (Register 86, No. 14). 

3. Change without regulatory effect repealing section and amending Note filed 
9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Reg- 
ister 2005, No. 36). 

§1498.4. Eligibility. 

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Section 
100275, Health and Safety Code; and Statutes of 1982, Chapter 159, Section 87(c). 
Reference: Sections 16703, 16706 and 16709, Welfare and Insfitutions Code. 

History 

1. Certificate of CompHance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No. 24). 

2. Amendment of subsecfions (b), (d), (e) and (f) filed 4-4-86; effective thirtieth 
day thereafter (Register 86, No. 14). 

3. Change without regulatory effect repealing secfion and amending Note filed 
9-7-2005 pursuant to section 1 00, title 1 , California Code of Regulations (Reg- 
ister 2005, No. 36). 

§ 1498.5. Benefits. 

NOTE: Authority cited: Secfion 10725, Welfare and Insdtufions Code; Secfion 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Secfion 16709, Welfare and Insfitutions Code. 

History 

1. Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83, No. 24). 

2. Change without regulatory effect repealing section and amending Note filed 
9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Reg- 
ister 2005, No. 36). 

§ 1498.6. Administration. 

Note: Authority cited: Secfion 10725, Welfare and Institutions Code; Secfion 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Sections 16709 and 16717, Welfare and Institutions Code. 



History 

1. Certificate of Compliance including editoiial correction of Ncm-: transmitted to 
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

2. Change without regulatory effect repealing section and amending NoTi-. filed 
9-7-2005 pursuant to section 1 00, fitie 1 , California Code of Regulations ( Reg- 
ister 2005, No. 36). 

§1498.7. Fiscal. 

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Section 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Sections 16703 and 16709, Welfare and Institutions Code. 

History 

1. Certificate of Compliance including editorial con-ection of Note; transmitted to 
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

2. Amendment filed 4^t-86; effective thirtieth day thereafter (Register 86, No. 
14). 

3. Change without regulatory effect repealing section and amending Noti-. filed 
9-7-2005 pursuant to section 100, fitle 1 , California Code of Regulations (Reg- 
ister 2005, No. 36). 

§1498.8. Liabilities. 

NOTE: Authority cited: Secfion 10725, Welfare and Institutions Code; Section 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Section 16709, Welfare and Institutions Code. 

History 

1 . Certificate of Compliance including editorial correcfion of Note transmitted to 
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24). 

2. Change without regulatory effect repealing section and amending Not?; filed 
9-7-2005 pursuant to section 100, tide 1 , California Code of Regulations (Reg- 
ister 2005, No. 36). 

§1498.9. Reporting. 

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Section 
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 
87(c). Reference: Sections 16709 and 16716, Welfai'e and Institutions Code. 

History 

1 . Certificate of Compliance including amendment transmitted to OAL 4-29-83 
and filed 6-9-83 (Register 83. No. 24) 

2. Change without regulatory effect repealing section and amending Note filed 
9-7-2005 pursuant to section 100. title 1. California Code of Regulations (Reg- 
ister 2005, No. 36). 



Chapter 3.1. Indian Health 



Article 1. Definitions 

§1500. Indian. 

"Indian" means any person who is: 

(a) Identified as an Indian on the rolls maintained by the Bureau of In- 
dian Affairs, 

(b) Identified as an Indian on the rolls maintained by an Indian tribe, 
band, or other organized group of Indians, in any state, 

(c) A descendant in the first or second degree of any person identified 
at any time on a roll referred to in subsection (a) or (b), 

(d) Declared to be a member of a tribe or a descendant in the first or 
second degree of a member of a tribe by the tribal council of his or her 
tribe, or 

(e) A descendant in any degree from a member of a tribe which has 
been declared to be terminated by the United States government. Howev- 
er, any person qualifying under this subsection must be at least one quar- 
ter Indian blood. 

NOTE: Authority cited: Sections 102 and 208, Health and Safetv Code. Reference: 
Sections 429.30, 429.31 and 429.32, Article 14, Chapter 2, Part 1, Division 1, 
Health and Safety Code. 

History 

1. New Chapter 3.1, Articles 1-4 (Sections 1500-1541, not consecutive) filed 
4-1-76 as an emergency; effective upon filing (Register 76, No. 14). 

2. Certificate of Compliance filed 7-14-6 (Register 76, No. 29). 

§1501. Indian Tribe. 

"Indian Tribe" means any Indian tribe, band, nation or other organized 
group or community, which is determined to be ehgible for the special 
programs and services provided by the United States or State of Califor- 
nia, to Indians because of their status as Indians. 



Page 51 



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§1502 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



§ 1502. Existing Indian Health Programs. 

"Existing Indian Health Programs" means any program which pro- 
vided, as of September 8, 1975, direct health services as defined in Sec- 
tion 1503 under the supervision of a licensed physician and surgeon, den- 
tist, optometrist, or nurse. 

§ 1 503. Direct Health Services. 

"Direct Health Services" means one or more of the following services 
provided under the supervision of a licensed provider of health services 
acting within the scope of his or her license: 

(a) Primary health care consisting of diagnostic, treatment and health 
maintenance services. 

(b) Outreach, education, referral, follow-up services and assistance to 
the individual in obtaining services from other agencies to which he is 
entitled (health advocacy). 

(c) Specialized health services as listed below: 

(1) Screening and disease detection services. 

(2) Alcohol and drug abuse detoxification services. 

(3) Dental health services. 

(4) Services leading to the prevention of vision and hearing loss and 
the restoration of vision and hearing. 

(5) Family planning services. 

(6) Maternal and child health services. 

(7) Medical care of chronic conditions. 

§ 1504. Licensed Provider of Health Services. 

"Licensed Provider of Health Services" for the purposes of Section 
1503 means: 

(a) A provider practicing in Cahfomia licensed by the appropriate 
healing arts board. 

(b) An individual employed by the Federal government in the practice 
of the healing arts on tribal lands. 

§1505. Department. 

"Department" means the State Department of Health Services. 
NOTE: Authority cited: Sections 208 and 11 82.2(d), Health and Safety Code. Ref- 
erence: Section 1 182.2, Health and Safety Code. 

History 
1. Editorial correction filed 12-7-84 (Register 84, No. 49. 

§1506. Director. 

"Director" means the Director of the State Department of Health Ser- 
vices. 

NOTE: Authority cited: Sections 208 and 1 1 82.2(d), Health and Safety Code. Ref- 
erence: Section 1182.2, Health and Safety Code. 

History 
1. Editorial correction filed 12-7-84 (Register 84, No. 49). 

§ 1507. Indian Medicine and Traditional Health Practices. 

"Indian Medicine and Traditional Health Practices" means traditional 
practices of Indian medicine which are native to an Indian community, 
which are accepted by that Indian community as handed down through 
the generations and which can be established through the collective 
knowledge of the elders of that Indian community. 
NOTE: Authority cited: Sections 208 and 1 182.2(d), Health and Safety Code. Ref- 
erence: Section 1182.2, Health and Safety Code. 

History 
1. New NOTE filed 12-7-84 (Register 84, No. 49). 



tor. The representatives of the California Urban Indian Health Council 
and the California Rural Indian Health Board shall be appointed by the 
Council and the Board. 



Article 3. 



Article 2. Indian Health Policy Panel 

§ 1520. Indian Health Policy Panel. 

An Indian Health Policy Panel established by the Director shall advise 
the Director regarding policy for Indian health. 

§ 1521. Panel Membership. 

Panel membership shall consist of four representatives of the Califor- 
nia Rural Indian Health Board, four representatives of the California Ur- 
ban Indian Health Council, and two individuals appointed by the Direc- 



Assistance to Indian Health 
Programs 



§ 1530. Financial Assistance to Indian Health Programs. 

Monies available under Chapter 606, Statutes of 1975, and any funds 
available to carry out provisions of Article 14 (commencing with Section 
429.30) ofChapter 2 of Part 1 of Division 1 of the Health and Safety Code 
shall be allotted for the following purposes: 

(a) Direct health services as defined under Section 1 503 of these regu- 
lations. 

(b) Technical assistance by individuals experienced in the delivery of 
health services including, but not limited to, health professionals, econo- 
mists, sociologists, accountants, legal advisors, midwives (to the extent 
otherwise permitted by law), and other experts in Indian medicine and 
traditional health practices. Technical assistance may be provided by 
State staff, by consultants under contract with the State, or through con- 
tracts with local public and voluntary health organizations or existing In- 
dian health programs. 

(c) Training for health workers in Indian programs provided in the fol- 
lowing manner: 

(1) On the job training using workers in the program or individuals 
from other projects or agencies as instructors. 

(2) Short term training sponsored by an educational facility not to ex- 
ceed two weeks duration at any one time or one day per week over a 
three-month period. 

(3) Tuition for the course work required by a staff member for the 
A. A., B.A. degree or advanced degree. 

(d) Studies concerning the health needs, resources and practices of 
California Indians. Special emphasis shall be placed on the area of Indian 
medicine and traditional health practices. 

§ 1531. Allocation of Financial Assistance to Indian Health 
Programs. 

(a) Funds shall be allocated for health services which are supplemental 
to those available from the Federal or State government. State funds 
available for the purposes of the Indian Health Service Program (Article 
14 (commencing with Section 429.30) ofChapter 2 of Part 1 of Division 
1 of the Health and Safety Code) shall not duplicate or replace any com- 
mitment made by the Federal government. 

(b) No funds shall be provided from those appropriated for the pur- 
poses of the Indian Health Service Program for types of services for 
which Indians are eligible under other programs and for which other 
funds are available, including but not limited to the following types of 
services: 

(1) Family planning. 

(2) Supplemental Feeding for Women, Infants and Children (WIC). 

(3) Alcoholism or substance abuse services. 

(4) Hospitalization other than for emergency services, if an individual 
is eligible for medical care under Title XVIII or XIX of the Federal Social 
Security Act, under the Workmen's Compensation Statutes of Califor- 
nia, from the Veteran's Administration or other similar programs or 
when a public health service hospital is accessible or if an individual has 
private health insurance. 

(5) Maternal and Child Health. 

(6) Crippled Childrens Services. 

(7) Community Mental Health Services Program (Short-Doyle). 

(8) Developmental Disability Program (Regional Centers). 

§ 1532. Allocation Formula. 

(a) In the determination of the allocation of State funds the following 
factors shall be considered: 
(1) Need as demonstrated by: 
(A) The number of individuals to be served. 



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§1540 



(B) The availability of other resources in the service area. 

(C) The accessibility of resources in the service area. 

(D) Higher costs of providing health services in the areas served. 

(2) The ability of the proposed program to meet that need, as deter- 
mined by: 

(A) Adequate personal services. 

(B) Sufficient operating expenses. 

(3) Compliance with statewide plan for Indian health services and ex- 
isting priorities for services. 

(4) Compliance with local Indian health plan. 

(5) The demonstrated ability of the Indian health program to carry out 
the proposed services. 

§ 1533. Reimbursement for Service. 

(a) The programs shall maximize utilization of reimbursement from 
third-party payors. 

(b) Where an Indian is eligible for health benefits from third-party 
payors and the service is provided by an existing Indian health program, 
the revenue collected from third-party payors shall be used to increase 
the services offered by the program. 

§ 1534. To Qualify for Funding. 

(a) To qualify for funding an existing Indian health program shall be 
administered by a nonprofit corporation organized under the laws of this 
State or by an Indian tribe as defined in Section 1501. The board of direc- 



tors or trustees of such corporation shall be composed of a majority of 
Indians as defined in Section 1500. 

NOTE: Authority cited: Sections 208 and 1 1 82.2(d), Health and Safety Code. Ref- 
erence: Sections 11 82 and 11 82.2, Health and Safety Code. 

History 

1. New NOTE filed 12-7-84 (Register 84, No. 49). 

§ 1535. Criteria for Reimbursement of Direct Services. 

(a) Salaries, travel expenses, and per diein rates for employees of exist- 
ing Indian health programs shall be no greater than the rate set for State 
employees in like circumstances. Exceptions shall be granted only when 
no provider of services is available to the program at the rate set for State 
einployees. 

(b) Rates for reimbursement of services provided on a fee-for-service 
basis shall be no greater than the prevailing rates in the community in 
which the provider of services offers services. 

Article 4. Standards of Service 

§ 1 540. Confidentiality of Information. 

(a) All patient files and information maintained or possessed by an ex- 
isting Indian health program shall be treated as privileged communica- 
tion, shall be held confidential, and shall not be divulged without the writ- 
ten consent of the individual or his personal representative, (or the parent 
or guardian, in the case of a minor), except as may be necessary to provide 
emergency services to the individual, to file a claim for benefits on behalf 



[The next page is 59.] 



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Title 17 



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§2500 



of the individual, or as required by the Department to administer this pro- 
gram. Information may be disclosed in summary, statistical, or other 
form which does not identify the particular individual. 

(b) Services shall be provided in a manner that respects the privacy and 
dignity of the individual. 

§ 1 541 . Informed Consent. 

(a) No individual shall be denied benefits available under the Indian 
Health Service Program for failure to accept any form of offered treat- 
ment. In the case of any medical treatment offered or given to an individ- 
ual under the Indian Health Services Program, a signed consent form 
shall be obtained indicating that the individual has been informed of all 
known risks, benefits, and alternatives to the proposed treatment. This re- 
quirement may be waived in the case of emergencies. In the case of mi- 
nors, the consent form shall be signed by the parent or guardian. 

Chapter 3.5. Joint Regulations for 
Handicapped Children 

Subchapter 1. Interagency Responsibilities 

for Providing Services to Handicapped 

Children 

§ 2000. Joint Regulations for Handicapped Children. 

CROSS-REFERENCE: See Title 2, Division 9, Chapter 1, Articles 
1-9, Sections 60000-60610, not consecutive. 

History 
1 . New Chapter 3.5 (Subchapter 1, Section 2000) printed as cross-reference only 

(Register 86, No. 21). 

Chapter 4. Preventive Medical Service 

(Originally Printed 8-15-45) 



Subchapter 1. Reportable Diseases and 
Conditions 



Article 1. Reporting 

§ 2500. Reporting to the Local Health Authority. 

(a) The following definitions shall govern the interpretation of this 
Subchapter. 

(1) 'CDC means the Centers for Disease Control and Prevention, 
United States Department of Health and Human Services. 

(2) 'CSTE' means the Council of State and Territorial Epidemiolo- 
gists. 

(3) 'MMWR' means the Morbidity and Mortality Weekly Report. 

(4) 'Case' means (A) a person who has been diagnosed by a health care 
provider, who is lawfully authorized to diagnose, using clinical judgment 
or laboratory evidence, to have a particular disease or condition listed in 
subsection (j); or (B) a person who meets the definifion of a case in Sec- 
tion 2564 - Diarrhea of the Newborn, Section 2574 - Food Poisoning, 
Section 26 1 2 Salmonella Infections (Other than Typhoid Fever), Section 
2628 - Typhoid Fever, or Section 2636 - Venereal Disease; or (C) a per- 
son who is considered a case of a disease or condition that satisfies the 
most recent communicable disease surveillance case definitions estab- 
lished by the CDC and published in the Morbidity and Mortality Weekly 
Report (MMWR) or its supplements; or (D) an animal that has been de- 
termined, by a person authorized to do so, to have rabies or plague. 

(5) 'Clinical signs' means the objective evidence of disease. 

(6) 'Clinical symptoms' means the subjective sensation of disease felt 
by the patient. 



(7) 'Communicable disease' means an illness due to a specific micro- 
biological or parasitic agent or its toxic products which arises through 
transmission of that agent or its products from an infected person, animal, 
or inanimate reservoir to a susceptible host, either directly or indirectly 
through an intermediate plant or animal host, vector, or the inanimate en- 
vironment. 

(8) 'Director' means State Director of Public Health. 

(9) 'Drug susceptibility testing' means the process where at least one 
isolate from a culture of a patient's specimen is subjected to antimicrobial 
testing to determine if growth is inhibited by drugs commonly used to 
treat such infections. 

(10) 'Epidemiological risk factors' means those attributes, behaviors, 
exposures, or other factors that alter the probability of disease. 

(11) 'Epidemiologically linked case' means a case in which the patient 
has/has had contact with one or more persons who have/had the disease, 
and transmission of the agent by the usual modes of transmission is plau- 
sible. 

( 1 2) 'Foodborne disease' means illness suspected by a health care pro- 
vider to have resulted from consuming a contaminated food. 

( 1 3) 'Foodborne disease outbreak' means an incident in which two or 
more persons experience a similar illness after ingestion of a common 
food, and epidemiologic analysis implicates the food as the source of the 
illness. There are two exceptions: even one case of botulism or chemical 
poisoning constitutes an outbreak if laboratory studies identify the caus- 
ative agent in the food. 

(14) 'Health care provider' means a physician and surgeon, a veteri- 
narian, a podiatrist, a nurse practitioner, a physician assistant, a regis- 
tered nurse, a nurse midwife, a school nurse, an infection control practi- 
tioner, a medical examiner, a coroner, or a dentist. 

(15) 'Health officer' and 'local health officer' as used in this subchap- 
ter includes county, city, and district health officers. 

(16) 'In attendance' means the existence of the relationship whereby 
a health care provider renders those services which are authorized by the 
health care provider's licensure or certification. 

(17) 'Infection control practitioner' means any person designated by 
a hospital, nursing home, clinic, or other health care facility as having re- 
sponsibilities which include the detection, reporting, control and preven- 
tion of infections within the institution. 

(18) 'Laboratory findings' means (A) the results of a laboratory ex- 
amination of any specimen derived from the human body which yields 
microscopical, cultural, immunological, serological, or other evidence 
suggesuve of a disease or condition made reportable by these regula- 
tions; or (B) the results of a laboratory examination of any specimen 
derived from an animal which yields evidence of rabies or plague. 

(19) 'Multidrug-resistantM>ro&6fr/^nM/n tuberculosis' means a labo- 
ratory culture or subculture of Mycobacterium tuberculosis which is de- 
termined by antimicrobial susceptibility testing to be resistant to at least 
isoniazid and rifampin. 

(20) 'Outbreak' means the occurrence of cases of a disease (illness) 
above the expected or baseline level, usually over a given period of time, 
in a geographic area or facility, or in a specific population group. The 
number of cases indicating the presence of an outbreak will vary accord- 
ing to the disease agent, size and type of population exposed, previous 
exposure to the agent, and the time and place of occurrence. Thus, the 
designation of an outbreak is relafive to the usual frequency of the disease 
in the same facility or community, among the specified population, over 
a comparable period of fime. A single case of a communicable disease 
long absent from a population or the first invasion by a disease not pre- 
viously recognized requires immediate reporting and epidemiologic in- 
vestigation. 

(21) 'Personal informafion' means any information that identifies or 
describes a person, including, but not limited to, his or her name, social 
security number, date of birth, physical description, home address, home 
telephone number, and medical or employment history. 

(22) 'Sexually Transmitted Diseases' means Chancroid. Lymphogra- 
nuloma Venereum, Granuloma Inguinale, Syphilis, Gonorrhea, Chlamy- 
dia, Pelvic Inflammatory Disease, and Nongonococcal Urethritis. 



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Title 17 



(23) 'Suspected case' means (A) a persi)n whom a health care provider 
believes, after weighing signs, symptoms, and/or laboratory evidence, to 
probably have a particular disease or condition listed in subsection (j); or 
(B) a person who is considered a probable case, or an epidemiologically- 
linked case, or who has supportive laboratory findings under the most re- 
cent communicable disease surveillance case definition established by 
CDC and published in the Morbidity and Mortality Weekly Report 
(MMWR) or its supplements; or (C) an animal which has been deter- 
mined by a veterinarian to exhibit clinical signs or which has laboratory 
findings suggestive of rabies or plague. 

(24) 'Unusual disease' means a rare disease or a newly apparent or 
emerging disease or syndrome of uncertain etiology which a health care 
provider has reason to believe could possibly be caused by a transmissi- 
ble infectious agent or microbial toxin. 

(25) 'Water-associated disease' means an illness in which there is evi- 
dence to suggest that the illness could possibly have resulted from physi- 
cal contact with or swallowing water from a microbiologically or chemi- 
cally contaminated source. Examples of such potentially contaminated 
water sources are lakes, rivers, streams, irrigation water, wells, public 
and private drinking water, bottled water, reclaimed water, ocean and bay 
waters, hot springs, hot tubs, whirlpool spas, and swimming pools. Epi- 
demiologic investigation by public health authorifies is required to dem- 
onstrate that a suspected water-associated illness was likely to have been 
waterborne and related to the suspected source. 

(26) 'Waterborne disease outbreak' means an incident in which two 
or more persons experienced a similar illness after consumption or use 
of the same water intended for drinking or after water contact such as by 
immersion, and epidemiologic invesfigation by public health authorifies 
implicates the same water as the source of the waterborne illness. There 
is one exception: a single case of waterborne chemical poisoning consti- 
tutes an outbreak if laboratory studies indicate that the source water is 
contaminated by the chemical. 

(b) It shall be the duty of every health care provider, knowing of or in 
attendance on a case or suspected case of any of the diseases or conditions 
listed in subsecfion (j) of this secfion, to report to the local health officer 
for the jurisdiction where the patient resides as required in subsection (h) 
of this section. Where no health care provider is in attendance, any indi- 
vidual having knowledge of a person who is suspected to be suffering 
from one of the diseases or conditions fisted in subsecfion (j) of this sec- 
fion may make such a report to the local health officer for the jurisdicfion 
where the pafient resides. 

(c) The administrator of each health facility, clinic or other setfing 
where more than one health care provider may know of a case, a sus- 
pected case or an outbreak of disease within the facility shall establish 
and be responsible for administrafive procedures to assure that reports 
are made to the local health officer. 

(d) Each report made pursuant to subsection (b) shall include all of the 
following informafion if known: 

(1) name of the disease or condition being reported; the date of onset; 
the date of diagnosis; the name, address, telephone number, occupation, 
race/ethnic group, Social Security numbei', sex, age, and date of birth for 
the case or suspected case; the date of death if death has occurred; and 
the name, address and telephone number of the person making the report. 

(2) If the disease reported pursuant to subsecfion (b) is hepafifis, a sex- 
ually transmitted disease or tuberculosis, then the report shall include the 
following applicable informafion, if known: (A) hepafifis information as 
to the type of hepafifis, type-specific laboratory findings, and sources of 
exposure, (B) sexually transmitted disease informafion as to the specific 
causative agent, syphilis-specific laboratory findings, and any compfica- 
fions of gonorrhea or chlamydia infecfions, or (C) tuberculosis informa- 
fion on the diagnosfic status of the case or suspected case, bacteriologic, 
radiologic and tuberculin skin test findings, informafion regarding the 
risk of transmission of the disease to other persons, and a list of the anti- 
tuberculosis medications administered to the patient. 

(e) Confidential Morbidity Report forms, PM 1 10 (1/90), are available 
from the local health department for reporting as required by this section. 

(f) Information reported pursuant to this section is acquired in confi- 
dence and shall not be disclosed by the local health officer except as au- 



thorized by these regulations, as required by state or federal law, or with 
the written consent of the individual to whom the information pertains or 
the legal representative of the individual. 

(g) Upon the State Department of Pubhc Health's request, a local 
health department shall provide to the Department the information re- 
ported pursuant to this section. Absent the individual's written consent, 
no information that would directly or indirectly identify the case or sus- 
pected case as an individual who has applied for or been given services 
for alcohol or other drug abuse by a federally assisted drug or alcohol 
abuse treatment program (as defined in federal law at 42 C.F.R. Secfion 
2.11) shall be included. 

(h) The urgency of reporting is idenfified by symbols in the list of dis- 
eases and condifions in subsecfion (j) of this secfion. Those diseases with 
a diamond ( ♦ ) are considered emergencies and shall be reported imme- 
diately by telephone. Those diseases and conditions with a cross {+) shall 
be reported by mailing, telephoning or electronically transmitfing a re- 
port within one (1) working day of idenfification of the case or suspected 
case. Those diseases and condifions not otherwise identified by a dia- 
mond or a cross shall be reported by mailing a written report, telephon- 
ing, or electronically transmitting a report within seven (7) calendar days 
of the time of identification. 

(i) For foodborne disease, the bullet (•) symbol indicates that, when 
two (2) or more cases or suspected cases of foodborne disease from sepa- 
rate households are suspected to have the same source of illness, they 
shall be reported immediately by telephone. 

(j) Health care providers shall submit reports for the following dis- 
eases or conditions. 

Acquired Immune Deficiency Syndrome (AIDS) 

+ Amebiasis 

♦ Anthrax 

♦ Avian Influenza (human) 
+ Babesiosis 

♦ Botulism (Infant, Foodborne, Wound, Other) 

♦ Brucellosis 

+ Campylobacteriosis 

Chancroid 
-I- Chickenpox (only hospitalization and deaths) 

Chlamydial Infections, including lymphogranuloma venereum 
(LGV) 

♦ Cholera 

♦ Ciguatera Fish Poisoning 
Coccidioidomycosis 

-I- Colorado Tick Fever 

+ Conjunctivitis, Acute Infectious of the Newborn, Specify 
Etiology 
Creutzfeldt-Jakob Disease (CJD) and other Transmissible 
Spongiform Encephalopathies (TSE) 
-t- Cryptosporidiosis 

Cysticercosis or taeniasis 

♦ Dengue 

♦ Diarrhea of the Newborn, Outbreaks 

♦ Diphtheria 

♦ Domoic Acid Poisoning (Amnesic Shellfish Poisoning) 
Ehrlichiosis 

-I- Encephafifis, Specify Etiology: Viral, Bacterial, Fungal, 
Parasific 

♦ Escherichia coli: shiga toxin producing (STEC) including 

£. CO// 0157 
-I- • Foodborne Disease 
Giardiasis 

Gonococcal Infecfions 
-I- Haemophilus influenzae, invasive disease (report an incident of 
less than 15 years of age) 

♦ Hantavirus Infections 



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§2500 



• 



♦ Hemolytic Uremic Syndrome 
Hepatitis, Viral 

+ Hepatitis A 

Hepatitis B (specify acute case or chronic) 
Hepatitis, C (specify acute case or chronic) 
Hepatitis D (Delta) 
Hepatitis, other, acute 

Influenza deaths (report an incident of less than 1 8 years of age) 
Kawasaki Syndrome (Mucocutaneous Lymph Node 

Syndrome) 
Legionellosis 
Leprosy (Hansen Disease) 
Leptospirosis 
+ Listeriosis 

Lyme Disease 
+ Malaria 

♦ Measles (Rubeola) 

+ Meningitis, Specify Etiology: Viral, Bacterial, Fungal, 
Parasitic 

♦ Meningococcal Infections 
Mumps 

♦ Paralytic Shellfish Poisoning 
Pelvic Inflammatory Disease (PID) 

+ Pertussis (Whooping Cough) 

♦ Plague, Human or Animal 
+ Poliomyelitis, Paralytic 

+ Psittacosis 
+ Q Fever 

♦ Rabies, Human or Animal 
+ Relapsing Fever 

Rheumatic Fever, Acute 
Rocky Mountain Spotted Fever 
Rubella (German JVdeasles) 
Rubella Syndrome, Congenital 
+ Salmonellosis (Other than Typhoid Fever) 

♦ Scombroid Fish Poisoning 

♦ Severe Acute Respiratory Infection (SARS) 

♦ Shiga toxin (detected in feces) 
+ Shigellosis 

♦ Smallpox (Variola) 

♦ Staphylococcus aureus infection (only a case resulting in death 

or admission to an intensive care unit of a person who has not 
been hospitalized or had surgery, dialysis, or residency in a 
long-term care facility in the past year, and did not have an 
indwelling catheter or percutaneous medical device at the 
time of culture.) 
+ Streptococcal Infections (Outbreaks of Any Type and 

Individual Cases in Food Handlers and Dairy Workers Only) 
+ Syphilis 
Tetanus 

Toxic Shock Syndrome 
Toxoplasmosis 
+ Trichinosis 
+ Tuberculosis 

♦ Tularemia 

+ Typhoid Fever, Cases and Carriers 

Typhus Fever 
+ Vibrio Infections 

♦ Viral Hemorrhagic Fevers (e.g., Crimean-Congo, Ebola, Lassa 

and Marburg viruses) 
+ Water-Associated Disease (e.g.. Swimmer's Itch and Hot Tub 

Rash) 
+ West Nile virus infection 



♦ Yellow Fever 
+ Yersiniosis 

♦ OCCURRENCE of ANY UNUSUAL DISEASE 

♦ OUTBREAKS of ANY DISEASE (Including diseases not 
listed in Section 2500). Specify if institutional and/or open 
community. 



( ♦ ) - to be reported immediately by telephone. 

(+) = to be reported by mailing a report, telephoning, or electronically 

transmitting a report within one ( 1 ) working day of identification of 
the case or suspected case. 

(No diamond or cross symbol) = to be reported within seven (7) calendar days by 
mail, telephone, or electronic report from the time of identification. 

(•) = when two (2) or more cases or suspected cases of foodbome disease 
from sepaiate households are suspected to have the same source of ill- 
ness, they should be reported immediately by telephone. 
NOTE: Authority cited: Sections 120130, 131080 and 131200, Health and Safety 
Code. Reference: Sections 1603.1. 100325, 103925, 113150, 113155, 120125, 
120130, 120140, 120175, 120245. 120250, 131050, 131051 and 131080. Health 
and Safety Code; Sections 551, 554 and 555, Business and Professions Code; Sec- 
tion 1798.3, Civil Code; 42 C.F.R. Sections 2. 1 1 and 2.12; Cal. Const., art. 1 , Sec- 
tion 1; and Section 1040, Evidence Code. 

History 

1. Originally published 8-15-1945 (Title 17). 

2. Amendment filed 12-22-69; effective thirtieth day thereafter (Register 69, No. 
52). For prior history, see Register 66, No. 39. 

3. Amendment filed 1 2-14-79; effective thirtieth day thereafter (Register 79, No. 
50). 

4. Amendment of subsection (a) and new subsections (b)-(h) filed 3-30-89; op- 
erative 3-30-89 (Register 89, No. 14). 

5. Editorial correction of History No. 4 printing error (Register 89, No. 23). 

6. Editorial correction of subsection (g)(1) printing error (Register 90, No. 4). 

7. Editorial con-ection of printing errors in subsection (g) (Register 91, No. 46). 

8. Amendment of section and Note filed 5-1-95 as an emergency; operative 
5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted 
to O AL by 8-29-95 or emergency language will be repealed by operation of law 
on the following day. 

9. Amendment of section and Note, including amendment of subsection (i)(l) 
"Diphtheria", refiled 8-21-95 as an emergency; operative 8-21-95 (Register 
95, No. 34). A Certificate of Compliance must be transmitted to OAL by 
12-19-95 or emergency language will be repealed by operation of law on the 
following day. 

10. Certificate of Compliance as to 5-1-95 order, including amendment of section, 
transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5). 

11. Editorial correction of subsections (j)(l) and (j)(2) (Register 97, No. 12). 

12. Amendment of subsection (j), repealer of subsection (j)(l) designator and ini- 
tial text, repealer of subsection (j)(2) and amendment of Note filed 5-17-2000; 
operative 10-2-2000 (Register 2000, No. 20). 

13. Editorial correction restoring inadvertently deleted footnote (Register 2000, 
No. 33). 

14. Amendment of subsection (j) and amendment of Note filed 1 1-5-2001 as an 
emergency; operative 11-5-2001 (Register 2001, No. 45). A Certificate of 
Compliance must be transmitted to OAL by 3-5-2002 or emergency language 
will be repealed by operation of law on the following day. 

15. Amendment of subsection (j) and amendment of Note refiled 3-1-2002 as an 
emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of Com- 
pliance must be transmitted to OAL by 7-1-2002 or emergency language will 
be repealed by operation of law on the following day. 

16. Certificate of Compliance as to 3-1-2002 order, including amendment of 
Note, transmitted to OAL 6-26-2002 and filed 7-1 6-2002 (Register 2002, No. 
29). 

17. Amendment of subsection (j) filed 6-30-2005; operative 6-30-2005. Sub- 
mitted to OAL for printing only pursuant to Health and Safety Code section 
120130 (Register 2005, No. 32). 

18. Amendment of subsection (j) filed 10-26-2006; operative 10-26-2006. Sub- 
mitted to OAL for printing only pursuant to Health and Safety Code section 
120130(a) and (d) (Register 2006, No. 43). 

19. Amendment of subsection (j) filed 6-12-2007; operative 6-12-2007. Sub- 
mitted to OAL for printing only pursuant to Health and Safety Code section 
120130 (Register 2007, No. 31). 

20. Amendment of subsection (j) filed 7-30-2007; operative 7-30-2007. Sub- 
mitted to OAL for printing only pursuant to Health and Safety Code .section 
120130 (Register 2007, No. 31). 

21. Amendment of subsections (a)(8), (g) and (j) and amendment of Note filed 
2-1 3-2008; operative 2-1 3-2008. Submitted to OAL for printing only pursuant 
to Health and Safety Code section 120130(a) and (d) (Register 2008, No. 7). 



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Title 17 



§ 2501. Investigation of a Reported Case, Unusual 
Disease, or Outbreak of Disease. 

(a) Upon receiving a report made pursuant to Section 2500 or 2505, 
the local health officer shall take whatever steps deemed necessary for 
the investigation and control of the disease, condition or outbreak re- 
ported. If the health officer finds that the nature of the disease and the cir- 
cumstances of the case, unusual disease, or outbreak warrant such action, 
the health officer shall make or cause to be made an examination of any 
person who or animal which has been reported pursuant to Sections 2500 
or 2505 in order to verify the diagnosis, or the existence of an unusual 
disease, or outbreak, make an investigation to determine the source of in- 
fection, and take appropriate steps to prevent or control the spread of the 
disease. Whenever requested to do so by the Department, the health offi- 
cer shall conduct a special morbidity and mortality study under Health 
and Safety Code Section 2 1 1 for any of the diseases made reportable by 
these regulations. 

(b) If a disease is one in which the local health officer determines iden- 
tification of the source of infection is important, and the source of infec- 
tion is believed to be outside the local jurisdiction, the health officer shall 
notify the Director or the health officer under whose jurisdiction the in- 
fection was probably contracted if known. Similar notification shall be 
given if there are believed to be exposed persons, living outside the juris- 
diction of the health officer, who should be quarantined or evaluated for 
evidence of the disease. 

Note: Authority cited: Sections 207, 208 and 3123, Health and Safety Code; and 
Section 555(b), Business and Professions Code. Reference: Sections 7, 200, 207, 
211. 211.5, 304.5, 410, 1603.1, 3051, 3053, 31 10. 3122, 3123, 3124, 3125, 3131 
and 3132, Health and Safety Code; Sections 551, 554 and 555, Business and Pro- 
fessions Code. 

History 

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

2. Amendment filed 3-30-89; operafive 3-30-89 (Register 89, No. 14). 

3. Amendment of section and Note, including renumbering and amendment of 
former section 2512 to subsecUon 2501(b)(l )-(2), filed 5-1-95 as an emergen- 
cy; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must 
be transmitted to OAL by 8-29-95 or emergency language will be repealed by 
operation of law on the following day. 

4. Amendment of section and Note refiled 8-21-95 as an emergency; operative 
8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted 
to OAL by 12-19-95 or emergency language will be repealed by operation of 
law on the following day. 

5. Certificate of Compliance as to 5-1-95 order, including repealer and new sec- 
tion heading, and amendment of section and Note transmitted to OAL 
12-19-95 and filed 2-2-96 (Register 96, No. 5). 

§ 2502. Reports by Local Health Officer to State 
Department of Public Health. 

(a) Summary Reports: Each local health officer shall report at least 
weekly, on the Weekly Morbidity by Place of Report form (DHS 8245 
(1 1/95)) to the Director the number of cases of those diseases, conditions, 
unusual diseases or outbreaks of disease reported pursuant to Section 
2500. Copies of the form are available from the Department's Division 
of Communicable Disease Control. 

(b) Individual Case and Outbreak Reports: For the diseases listed be- 
low, the local health officer shall prepare and send to the Department 
along with the summary report described in (a) above an individual case 
or outbreak report for each individual case/outbreak of those diseases 
which the Department has identified as requiring epidemiological analy- 
sis reported pursuant to Section 2500. At the discretion of the Director, 
the required individual case/outbreak report may be either a Confidential 
Morbidity Report (PM-1 10 1/90), its electronic equivalent or a hard copy 
8.5x1 1 inch individual case/outbreak report form. The Weekly Morbid- 
ity by Place of Report form (DHS 8245 1 1/95)) indicates which format 
to use. Each individual case report shall include the following: (1) verifi- 
cation of information reported pursuant to Section 2500; (2) information 
on the probable source of infection, if known; (3) laboratory or radiologic 
findings, if any; (4) clinical signs and/or symptoms, if applicable; and (5) 
any known epidemiological risk factors. The Department or CDC has 
prepared forms that may be used for many of the diseases requiring indi- 
vidual case reports. Where a form exists, its identification number is 



listed in parentheses next to the diseases listed below. Copies of these 
case report forms are available from the Department's Division of Com- 
municable Disease Control. An individual case report is required for the 
following diseases: 

Acquired Immune Deficiency Syndrome (AIDS) (CDC 50.42B) 

Anthrax (ACD-152) 

Avian Influenza (human) (pending) 

Botulism (Infant, Foodbome, Wound, Other) (ACD-153) 

Brucellosis (262-101) 

Chickenpox (Varicella) deaths (separate reporting form required) 

Chickenpox (Varicella) hospitalizations (separate reporting form 
required) 

Cholera (CDC 52.79) 

Creutzfeldt-Jakob Disease (CJD) and other Transmissible Spongi- 
form Encephalopathies (TSE) (pending) 

Cysticercosis (pending) 

Diarrhea of the Newborn, Outbreaks (262-504) 

Diptheria (262-505) 

Escherichia coli: shiga toxin producing (STEC) including 
E.coliOl51 

Foodbome Disease Outbreak (CDC 52.13) 

Haemophilus influenzae. Invasive Disease (DHS 8449) 

Hantavirus Infections (pending) 

Hemolytic Uremic Syndrome (pending) 

Hepatitis A (CDC 53.1) 

Hepatitis B, acute only (CDC 53.1) 

Hepatitis C, acute only (CDC 53.1) 

Hepatitis D (Delta), acute only (CDC 53.1) 

Hepatitis, any other acute viral type (CDC 53.1) 

Influenza deaths (report an incident of less than 1 8 years of age) 
(pending) 

Kawasaki Syndrome (Mucocutaneous Lymph Node Syndrome) 
(DHS 8468) 

Legionellosis (CDC 52.56) 

Leprosy (Hansen Disease) (CDC 52.18) 

Leptospirosis (262-102) 

Listeriosis (DHS 8296) 

Lyme Disease (DHS 8470) 

Malaria (CDC 54.1) 

Measles (Rubeola) (DHS 8345) 

Meningoccal Infections (DHS 8469) 

Outbreak of Disease Report (DHS 262-501) 

Pelvic Inflammatory Disease (PID) 

Pertussis (Whooping Cough) (DHS 8258) 

Plague (CDC 56.37) 

Poliomyelitis, Paralytic (DHS 8421) 

Psittacosis (8023-005) 

Q Fever (262-101) 

Rabies, Human or Animal (Humans 262-105, Animals PM 102) 

Relapsing Fever (262-107) 

Rocky Mountain Spotted Fever (CDC 55.1) 

Rubella (German Measles) (PM 358; for Congenital Rubella, CDC 
71.17) 

Severe Acute Respiratory Infection (SARS) (pending) 

Shiga toxin (detected in feces) 

Smallpox (pending) 

Staphylococcus aureus infection (only a case resulting in death or ad- 
mission to an intensive care unit of a person who has not been hospital- 
ized or had surgery, dialysis, or residency in a long-term care facility in 
the past year, and did not have an indwelling catheter or percutaneous 
medical device at the time of culture.) 

Streptococcal Outbreaks and Individual Cases in Food Handlers and 
Dairy Workers Only 

SyphiUs (for Congenital Syphilis, CDC 73.126) 

Tetanus (CDC 71.15) 

Toxic Shock Syndrome (CDC 52.3) 



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• 



Trichinosis (CDC 54.7) 

Tuberculosis (CDC 72.9 A, B, and C) 

Tularemia (262-101) 

Typhoid Fever, Cases and Carriers (Cases, CDC 52.5; Carriers, CDC 

4.383) 
Typhus Fever (262-107) 
Unusual Disease Report (DHS 262-501) 
Vibrio Infections (CDC 52.79) 
Viral Hemorrhagic Fevers (pending) 
Waterbome Disease Outbreak (CDC 52.12) 
West Nile virus infection (pending) 
Yellow Fever 

(c) Immediate Reports: Cases and suspect cases of anthrax, botulism, 
brucellosis, cholera, dengue, diarrhea of the newborn (outbreaks), diph- 
theria, plague, rabies (human only), smallpox (varoila), tularemia, vari- 
cella deaths, viral hemorrhagic fevers, yellow fever, occurrence of any 
unusual diseases, and outbreaks of any disease are to be reported by the 
local health officer to the Director immediately by telephone. 

(d) Upon request of the Department, the local health officer shall sub- 
mit an individual case report for any disease not listed in subsection (b) 
above. 

(e) During any special morbidity and mortality study requested under 
Section 2501 , the local health officer shall be the Director's agent for pur- 
poses of carrying out the powers conferred under Government Code Sec- 
tion 11181. 

(f) Confidentiality. Information reported pursuant to this section is ac- 
quired in confidence and shall not be disclosed by the local health officer 
except as authorized by these regulations, as required by state or federal 
law, or with the written consent of the individual to whom the informa- 
tion pertains or to the legal representative of that individual. 

( 1 ) A health officer shall disclose any information, including personal 
information, contained in an individual case report to state, federal or lo- 
cal public health officials in order to determine the existence of a disease, 
its likely cause or the measures necessary to stop its spread. 

(2) A health officer may for purposes of his or her investigation dis- 
close any information contained in an individual case report, including 
personal information, as may be necessary to prevent the spread of dis- 
ease or occurrence of additional cases. 

(3) A health officer may disclose any information contained in an indi- 
vidual case report to any person or entity if the disclosure may occur with- 
out linking the information disclosed to the individual to whom it per- 
tains, and the purpose of the disclosure is to increase understanding of 
disease patterns, to develop prevention and control programs, to commu- 
nicate new knowledge about a disease to the community, or for research. 

(4) Notwithstanding subsections (1), (2), and (3) above, no informa- 
tion that would directly or indirectly identify an individual as one who 
has applied for or been given services for alcohol or other drug abuse by 
a federally assisted drug or alcohol abuse treatment program (as defined 
in 42 C.F.R. § 2. 1 1 ) shall be included in an individual case report or other- 
wise disclosed absent the individual's written consent. 

(g) Whenever the health officer collects personal information in order 
to prepare an individual case report required by subsection (b). the health 
officer shall notify the individual from whom the information is collected 
that: (1) supplying personal information related to the individual's dis- 
ease is mandatory; (2) the only disclosure of personal information will 
be pursuant to subsections 2502(f(l) and 2502(f)(2); and (3) non-perso- 
nal information may be disclosed pursuant to subsection 2502(f)(3). 
NOTli; Authority cited: Sections 120130, 131080 and 131200, Health and Safety 
Code; and Section 555(b), Business and Professions Code. Reference: Sections 7, 
1603.1, 100325. 100330, 103925, 113150, 113155, 120125, 120130, 120140, 
120145, 120175, 120190, 120245, 120250, 131050, 131051 and 131080, Health 
and Safety Code; and Sections 55 1 , 554 and 555, Business and Professions Code; 
Section 1798.3, Civil Code; Sections 11181 and 11182, Government Code; 42 
C.F.R. Sections 2.11 and 2.12.; Cal. Const., art. 1, Section 1; and Section 1040, 
Evidence Code. 



History 

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

2. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14). 

3. Amendment filed 5-1-95 as an emergency; operative 5-1-95 (Register 95. No. 
18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or 
emergency language will be repealed by operation of law on the following day. 

4. Amendment refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95, 
No. 34). A Certificate of Compliance must be transmitted to OAL by 12 19 95 
or emergency language will be repealed by operation of law on the following 
day. 

5. Certificate of Compliance as to 5-1-95 order, including repealer and new sec- 
tion heading, section and Note transmitted to OAL 12-19-95 and filed 2-2-96 
(Register 96, No. 5). 

6. Editorial conection of subsection (c) (Register 97, No. 12). 

7. Amendment of subsections (b)-(c) and amendment of NoTH filed 1 1-5-2001 
as an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A Certificate 
of Compliance must be transmitted to OAL by 3-5-2002 or emergency lan- 
guage will be repealed by operation of law on the following day. 

8. Amendment of subsections (b)-(c) and amendment of NoTi-. refiled 3-1-2002 
as an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of 
Compliance must be transmitted to OAL by 7-1-2002 or emergency language 
will be repealed by operation of law on the following day. 

9. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 
and filed 7-16-2002 (Register 2002, No. 29). 

10. Amendment of subsection (b) filed 6-30-2005; operative 6-30-2005. Sub- 
mitted to OAL for printing only pursuant to Health and Safety Code section 
120130 (Register 2005, No. 32). 

11. Amendment of subsection (b) 6-12-2007; operative 6-12-2007. Submitted 
to OAL for printing only pursuant to Health and Safety Code section 120130 
(Register2007, No. 31). 

12. Amendment of subsection (b) filed 7-30-2007; operative 7-30-2007. Sub- 
mitted to OAL for printing only pursuant to Health and Safety Code section 
120130 (Register 2007, No. 31). 

13. Amendment of section heading, subsection (b) and Noth filed 2-1 3-2008; op- 
erative 2-13-2008. Submitted to OAL for printing only pursuant to Health and 
Safety Code secfion 120130(a) and (d) (Register 2008, No. 7). 

§ 2503. Reporting Occurrence of Unusual Diseases. 

Note.- Authority cited: Sections 207, 208 and 3 123, Health and Safety Code. Ref 
erence: Sections 200, 207, 3053, 31 10, 3123, 3124 and 3125, Health and Safety 
Code. 

History 

1. New section filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

2. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14). 

3. Amendment of section heading and section filed 5-1-95 as an emergency; op- 
erative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be 
transmitted to OAL by 8-29-95 or emergency language will be repealed by op- 
eration of law on the following day. 

4. Amendment of section heading and section refiled 8-21-95 as an emergency; 
operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be 
transmitted to OAL by 12-19-95 or emergency language will be repealed by 
operation of law on the following day. 

5. Certificate of Compliance as to 5-1-95 order, including repealer of section 
transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5). 

§ 2504. Report by Health Care Provider of Out-of-State 
Laboratory Findings. 

Whenever a health care provider' s identification of a case or suspected 
case of tuberculosis includes laboratory findings from an out-of-state 
laboratory, the health care provider shall include those findings with the 
report made pursuant to SecUon 2500(b), and if the laboratory performed 
drug susceptibility tesfing, the results of such testing shall also be so re- 
ported. 

Note: Authority cited: Sections 207, 208 and 3 123, Health and Safety Code. Ref 
erence: Sections 200, 207, 3053, 3110, 3123, 3125 and 3285, Health and Safety 
Code. 

History 

1 . Amendment of section heading, repealer and new section, and new NoTi filed 
5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 1 8). A Certificate 
of Compliance must be transmitted to OAL by 8-29-95 or emergency language 
will be repealed by operation of law on the following day. 

2. Repealer and new section refiled 8-2 1 -95 as an emergency; operative 8-2 1 -95 
(Register 95, No. 34). A Certificate of Compliance must be tran.smitted to OAL 



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§2505 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



by 12-19-95 or emergency language will be repealed by operation of law on 
the following day. 
3. Certificate of Compliance as to 5-1-95 order transmitted to OAL 1 2-1 9-95 and 
filed 2-2-96 (Register 96, No. 5). 

§ 2505. Notification by Laboratories. 

(a) To assist the local health officer, the laboratory director, or the lab- 
oratory director's designee, of a clinical laboratory, an approved public 
health laboratory or a veterinary laboratory in which a laboratory exami- 
nation of any specimen derived from the human body (or from an animal, 
in the case of rabies or plague testing) yields microscopical, cultural, im- 
munological, serological, or other evidence suggestive of those diseases 
listed in subsections (e)(1) and (e)(2) below, shall report such findings to 
the health officer of the local health jurisdiction where the health care 
provider who first submitted the specimen is located. 

(1) For those diseases listed in subsection (e)(1), the report of such 
findings shall be made within one hour after the laboratory notifies the 
health care provider or other person authorized to receive the report. If 
the laboratory that makes the positive finding received the specimen 
from another laboratory, the laboratory making the positive finding shall 
notify the health officer of the jurisdiction in which the health care pro- 
vider is located within one hour from the time the laboratory notifies the 
referring laboratory that submitted the specimen. 

(2) For those diseases listed in subsection (e)(2), the report of such 
findings shall be made within one working day from the time that the lab- 
oratory notifies the health care provider or other person authorized to re- 
ceive the report. If the laboratory that makes the positive finding received 
the specimen from another laboratory, the laboratory making the positive 
finding shall notify the health officer of the jurisdiction in which the 
health care provider is located within one working day from the time the 
laboratory notifies the referring laboratory that submitted the specimen. 

(b) To permit local health officer follow-up of laboratory findings, all 
specimens submitted for laboratory tests or examinations related to a dis- 
ease or condition listed in subsections 25()5(e)(l) or 2502(e)(2) shall be 
accompanied by a test requisition which includes the name, gender, and 
age or date-of-birth of the person from whom the specimen was obtained 
and the name, address and telephone number of the health care provider 
or other authorized person who submitted the specimen. Whenever the 
specimen, or an isolate therefrom, is transferred between laboratories, a 
test requisition with the above patient and submitter information shall ac- 
company the specimen. The laboratory that first receives a specimen 
shall be responsible for obtaining the patient and submitter information 
at the time the specimen is received by that laboratory. 

(c) Each notification to the local health officer shall include the date 
the specimen was obtained, the patient identification number, the speci- 
men accession number or other unique specimen identifier, the laborato- 
ry findings for the test performed, the date that any positive laboratory 
findings were identified, the name, gender, address, telephone number (if 
known) and age or date of birth of the person from whom the specimen 
was obtained, and the name, address, and telephone number of the health 
care provider for whom such examination or test was performed. 

(d) The notification shall be submitted as specified in subsections 
(e)(1) and (e)(2) of this Section to the local health officer in the jurisdic- 
tion where the health care provider who submitted the specimen is lo- 
cated. When the specimen is from an out-of-state submitter, the state 
epidemiologist of the submitter shall be provided the same positive find- 
ings per subsections (e)(1) and (e)(2) of thi s SecUon. If the laboratory that 
finds evidence for any of those diseases listed in subsections (e)(1) and 
(e)(2) is an out-of-state laboratory, the California clinical laboratory that 
receives a report of such findings from the out-of-state laboratory shall 
notify the local health officer in the same way as if the finding had been 
made by the California laboratory. 

(e) Laboratory reports to the local health officer shall include the in- 
formadon as specified in (c) of this Section and laboratories shall submit 
the reports within the following timeframes: 

(1) The diseases specified shall be reported within one hour after the 
health care provider or other person authorized to receive the report has 



been notified. Laboratories shall make the initial reports to the local 
health officer by telephone and follow the initial report within one work- 
ing day by a report in writing submitted by electronic facsimile transmis- 
sion or electronic mail to the local health officer. The diseases reported 
pursuant to this requirement are: 

Anthrax (see section 255 1 for additional reporting instmctions) 

Avian Influenza (see (j) for additional reporting requirements) 

Botulism (see section 2552 for additional reporting instructions) 

Brucellosis, by isolation of Brucella species from a clinical specimen, 
or demonstration by immunofluorescence of Brucella species in a clini- 
cal specimen, or fourfold or greater rise in antibody titer to Brucella anti- 
gen between acute and convalescent phase seiTim specimens obtained 
two or more weeks apart and studied at the same laboratory, or elevated 
serum antibody to Brucella antigen at a titer of 1 : 1 60 or greater in a single 
serum specimen, (see section 2553 for special reporting instructions) 

Burkholderia pseudomallei and B. mallei 

Plague, animal or human (see section 2596 for additional reporting 
instructions) 

Smallpox (Variola) (see section 2614 for additional reporting instruc- 
tions) 

Tularemia, by isolation of Francisella tularensis in a clinical speci- 
men, or demonstration by immunofluorescence of F. tularensis in a clini- 
cal specimen, or fourfold or greater rise in antibody titers to F. tularensis 
antigen between acute and convalescent phase serum specimens ob- 
tained two or more weeks apart and studied at the same laboratory, or ele- 
vated antibody to F. tularensis antigen at a titer of 1:160 or greater in a 
single serum specimen, (see section 2626 for additional reporting 
instructions) 

Viral Hemorrhagic Fever agents, e.g., Crimean-Congo, Ebola, Lassa, 
and Marburg viruses (see section 2638 for additional reporting instruc- 
tions) 

(2) The diseases specified shall be reported within one working day 
after the health care provider or other person authorized to receive the re- 
port has been notified. Laboratories shall transmit these reports to the lo- 
cal health officer by courier, mail, electronic facsimile or electronic mail. 
The diseases reported pursuant to this requirement are: 

Acid fast bacillus (AFB) (see (g) for additional reporting require- 
ments) 

Bordetella pertusis acute infection, by culture or molecular identifica- 
tion 

Borrelia burgdorferi infection 

Chlamydial infections, including lymphogranuloma venereum (LGV) 

Cryptosporidiosis 

Cyclospora cayetanensis 

Diphtheria 

Encephalitis, arboviral 

Escherichia coli: shiga toxin producing (STEC) including E. coli 
0157 

Gonorrhea 

Haemophilus influenzae (report an incident of less than 15 yers of age, 
sterile site) 

Hepatitis A, acute infection, by IgM anitbody test or positive viral anti- 
gen test 

Hepatitis B, acute infection, by IgM anti-HBc anitbody test 

Hepatitis B surface antigen positively (specify gender) 

Hepatitis C (see (i) for additional reporting requirements) 

Legionella (antigen or culture) 

Listeria 

Malaria (see (h) for additional reporting requirements) 

Measles (Rubeola), acute infection, by IgM anitbody test or positive 
viral antigen test 

Mycobacterium tuberculosis (see (f) for additional reporting require- 
ments) 

Neisseria meningitidis (sterile site isolate) 

Rabies, animal or human 

Rubella, acute infection by IgM antibody test or culture 



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Title 17 



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§2505 



Salmonella sp. 

Shiga toxin (detected in feces) 

Shigella sp. 

Syphilis 

Tuberculosis 

Typhoid 

Vibrio species infections 

West Nile virus infection 

(f) In addition to notifying the local health officer pursuant to subsec- 
tion (a), any clinical laboratory or approved public health laboratory that 
isolates Mycobacterium tuberculosis from a patient specimen shall: 

(1) Submit a culture as soon as available from the primary isolate on 



which a diagnosis of tuberculosis was established. Such a culture shall 
be submitted to the public health laboratory designated in Title 17 Cali- 
fornia Code of Regulations, Section 1075 for the local jurisdiction where 
the health care provider's office is located. The following information 
shall be submitted with the culture: the name, address, and the date of 
birth of the person from whom the specimen was obtained, the patient 
identification number, the specimen accession number or other unique 
specimen identifier, the date the specimen was obtained from the patient, 
and the name, address, and telephone number of the health care provider 
for whom such examination or test was performed. The public health lab- 
oratory shall retain the culture received (one culture from each culture- 
positive patient) in a viable condition for at least six months. 



[The next page is 65.] 



• 



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Title 17 



State Department of Health Services 



§2508 



(2) Unless drug susceptibility testing has been performed by the clini- 
cal laboratory on a strain obtained from the same patient within the pre- 
vious three months or the health care provider who submitted the speci- 
men for laboratory examination informs the laboratory that such drug 
susceptibility testing has been performed by another laboratory on a cul- 
ture obtained from that patient within the previous three months, the clin- 
ical laboratory shall: 

(A) Perform or refer for drug susceptibility testing on at least one iso- 
late from each patient from whom Mycobacterium tuberculosis was iso- 
lated; and 

(B) Report the results of drug susceptibility testing to the local health 
officer of the city or county where the submitting physician's office is lo- 
cated within one working day from the time the health care provider or 
other authorized person who submitted the specimen is notified; and 

(C) If the drug susceptibility testing determines the culture to be resis- 
tant to at least isoniazid and rifampin, in addition, submit one culture or 
subculture from each patient from whom multidrug-resistant Mycobac- 
terium tuberculosis was isolated to the official public health laboratory 
designated in Title 17 California Code of Regulations Section 1075 for 
the local health jurisdiction in which the health care provider's office is 
located. The local public health laboratory shall forward such cultures to 
the Department's Microbial Diseases Laboratory. The following infor- 
mafion shall be submitted with the culture: the name, address, and the 
date of birth of the person from whom the specimen was obtained, the pa- 
tient identification number, the specimen accession number or other 
unique specimen idendfier, the date the specimen was obtained from the 
patient, and the name, address, and telephone number of the health care 
provider for whom such examination or test was performed. 

(g) Whenever a clinical laboratory finds that a specimen from a padent 
with known or suspected tuberculosis tests positive for acid fast bacillus 
(AFB) staining and the padent has not had a culture which idendfies that 
acid fast organism within the past 30 days, the clinical laboratory shall 
culture and idendfy the acid fast bacteria or refer a subculture to another 
laboratory for those purposes. 

(h) In addidon to notifying the local health officer pursuant to subsec- 
tion (a), any clinical laboratory that makes a finding of malaria parasites 
in the blood film of a patient shall immediately submit one or more such 
blood film slides for confirmadon to the public health laboratory desig- 
nated in Tide 1 7 California Code of Reguladons Secdon 1 075 for the lo- 
cal health jurisdicdon where the health care provider is located. When re- 
quested, all blood films shall be returned to the submitter. 

(i) Any laboratory with a posidve hepatids C virus (HCV) test that 
meets the CDC laboratory criteria for diagnosis of HCV infecdon in a 
California resident shall report the positive test to the local health officer. 

The following test results are reportable. 

( 1 ) All HCV posidve recombinant immunoblot assay (RIBA) tests; 

(2) All HCV RNA positive tests [e.g., nucleic acid tests (NAT)]; 

(3) All HCV genotype reports; and 

(4) And-HCV reactive by a screening test (e.g., enzyme immunoassay 
[EIA] or chemiluminescence immunoassay [CIA]) with either: 

(A) The exact signal-to-cut-off (s/co) rado or index value; or 

(B) A comment that indicates whether or not the screening test s/co ra- 
do or index value is predictive of a true posidve as determined for the par- 
dcular assay as defined by the CDC in the case definidon for "laboratory 
criteria for diagnosis" of Hepadtis C virus infecdon, past or present. The 
url for the s/co ratios that meet the CDC case definition is 
http://www.cdc.gOv/ncidod/diseases/hepadds/c/sc_ratios.htm. 

If a laboratory chooses to report a reactive anti-HCV screening test 
(e.g., EIA or CIA test) with a s/co or index value that is lower than re- 
quired to meet the CDC case definidons AND does not report the exact 
s/co or index value (i.e., the laboratory report is posidve without a specif- 
ic s/co or index value reported), then the laboratory report MUST include 
a comment to indicate that the s/co or index value is low and that supple- 
mental testing (e.g., RIBA or NAT) is recommended by the CDC. 



(j) Whenever a laboratory receives a specimen for the laboratory diag- 
nosis of avian influenza in a human such laboratory shall communicate 
immediately by telephone with the Department's Viral and Rickettsial 
Disease Laboratory for instrucdon. 

(k) All laboratory notificadons herein required are acquired in confi- 
dence and shall not be disclosed by the local health officer except (1 ) as 
authorized by these reguladons; (2) as required by state or federal law ; 
or (3) with the written consent of the individual to whom the information 
pertains or the legal representative of that individual. 

(/) The local health officer shall disclose any information, including 
personal information, contained in a laboratory notification to state, fed- 
eral or local public health officials in order to determine the existence of 
the disease, its likely cause and the measures necessary to stop its spread. 

NOTE; Authority cited: Sections 100180, 100275, 120130 and 125095. Health and 
Safety Code. Reference: Sections 100180, 120125, 120130. 120140. 120175. 
120575, 121365 and 125100, Health and Safety Code; Sections 1209. 1246.5 and 
1288, Business and Professions Code; Cal. Const.., art. 1, Section 1; and Section 
1040, Evidence Code. 

History 

1. New section fded 3-26-62; effective thirtieth day thereafter (Register 62, 
No.6). 

2. Amendment of subsections (a) and (b) filed 6-25-72 as an emergency; effective 
upon filing (Register 72, No. 27). 

3. Certificate of Compliance filed 10-24-72 (Register 72, No. 44). 

4. Amendment of subsection (d) filed 3-30-89; operative 3-30-89 (Register 89. 
No. 14). 

5. Amendment of section and Notf; filed 5-1-95 as an emergency; operative 
5-1 -95 (Register 95, No. 18). A Certificate of Compliance must be transmitted 
to OAL by 8-29-95 or emergency language will be repealed by operation of law 
on the following day. 

6. Amendment of section and Note refiled 8-21-95 as an emergency; operative 
8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted 
to OAL by 12-19-95 or emergency language will be repealed by operation of 
law on the following day. 

7. Certificate of Compliance as to 5-1-95 order, including amendment of section, 
transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5). 

8. Change without regulatory effect amending subsection (c) filed 7-15-97 pur- 
suant to section 100, title 1, California Code of Regulations (Register 97, No. 
29). 

9. Amendment of subsections (a)-(d), repealer of subsection (e) and new subsec- 
tions (e)-(e)(2) and amendment of Noth filed 1 1-5-2001 as an emergency; op- 
erative 1 1-5-2001 (Register 2001, No. 45). A Certificate of Compliance must 
be transmitted to OAL by 3-5-2002 or emergency language will be repealed by 
operation of law on the following day. 

10. Amendment of subsections (a)-(d), repealer of subsection (e), new subsections 
(e)-(e)(2) and amendment of NoTi- refiled 3-1-2002 as an emergency; opera- 
tive 3-1-2002 (Register 2002, No. 9). A Certificate of Compliance must be 
transmitted to OAL by 7-1-2002 or emergency language will be repealed by 
operation of law on the following day. 

1 1 . Certificate of Compliance as to 3-1-2002 order, including further amendment 
of subsection (e)(1), transmitted to OAL 6-26-2002 and filed 7-1 6-2002 ( Reg- 
ister 2002, No. 29). 

12. Amendment of subsection (e)(2) filed 6-30-2005; operative 6-30-2005. Sub- 
mitted to OAL for printing only pursuant to Health and Safety Code section 
120130 (Register 2005, No. 32). 

13. Amendment of subsection (e)(2) filed 10-26-2006; operative 10-26-2006. 
Submitted to OAL for printine only pursuant to Health and Safety Code section 
120130(a) and (d) (Register 2006, No. 43). 

14. Amendment of subsections (e)(l )-(2), new subsections (i)-(j) and subsection 
relettering filed 6-12-2007; operative 6-12-2007. Submitted to OAL for print- 
ing only pursuant to Health and Safety Code section 1 20 1 30 (Register 2007. No. 
31). 

15. Amendment of subsection (e)(2) filed 7-30-2007; operative 7-30-2007. Sub- 
mitted to OAL for printing only pursuant to Health and Safety Code section 
120130 (Register 2007, No. 31). 

§ 2508. Reporting by Schools. 

It shall be the duty of anyone in charge of a public or private school, 
kindergarten, boarding school, or day nursery to report at once to the lo- 
cal health officer the presence or suspected presence of any of the com- 
municable diseases. 



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§2509 



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§ 2509. Records of Local Health Officer. 

The local health officer shall maintain such records as he deems neces- 
sary in the performance of his duties, or as requested by the State Depart- 
ment of Health Services. 

§ 2510. Outbreaks of Nonreportable Diseases. 

History 

1 . Repealer filed 7-29-55; effective thirtieth day thereafter (Register 55, No. 1 1 ). 

§ 251 1 . Determination of Morbidity Level. 

It shall be the duty of the local health officer to determine the amount 
and kind of communicable disease occurring in his area by such methods 
as he deems necessary in order to obtain knowledge of the general level 
of morbidity in his jurisdiction. 

History 
1. New section filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 



§2512. 



Article 2. General Instructions 

Investigation of the Case. 

History 



1. Renumbering and amendment of former section 2512 to subsection 
2501(b)(l)-(2) filed 5-1-95 as an emergency; operative 5-1-95 (Register 95, 
No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 
or emergency language will be repealed by operation of law on the following 
day. 

2. Renumbering and amendment of former section 2512 to subsection 
2501(b)(l)-(2) refiled 8-21-95 as an emergency; operative 8-21-95 (Register 
95, No. 34). A Certificate of CompUance must be transmitted to OAL by 
12-19-95 or emergency language will be repealed by operafion of law on the 
following day. 

§ 2514. Instructions to Household. 

It shall be the duty of the health care provider in attendance on a case 
or suspected case of any disease or condition listed in Sections 2500, or 
of any other disease considered to be communicable, to give detailed in- 
structions to the members of the household in regard to precautionary 
measures to be taken for preventing the spread of the disease or condi- 
tion. Such instructions shall conform to these regulations and local ordi- 
nances. It is the responsibility of each health care provider to be informed 
as to these regulations and the local ordinances which are in effect in the 
communities in which the health care provider practices. 
Note-. Authority cited: Sections 207, 208 and 3 1 23, Health and Safety Code. Ref- 
erence: Sections 207, 208, 3123 and 3285, Health and Safety Code. 

History 

1 . Amendment of section and new Note filed 5-1-95 as an emergency; operative 
5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted 
to OAL by 8-29-95 or emergency language will be repealed by operation of law 
on the following day. 

2. Amendment of section and Note refiled 8-21-95 as an emergency; operadve 
8-2 1-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted 
to OAL by 12-19-95 or emergency language will be repealed by operation of 
law on the following day. 

3. Certificate of Compliance as to 5-1-95 order, including amendment of section, 
transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5). 

§2515. Definition of Isolation. 

Isolation is defined as separation of infected persons from other per- 
sons for the period of communicability in such places and under such 
conditions as will prevent the transmission of the infectious agent. Isola- 
tion will be applied as instructed below. 

§2516. Strict Isolation. 

If the disease is one requiring strict isolation, the health officer shall 
insure that instructions are given to the patient and members of the house- 
hold, defining the area within which the patient is to be isolated and stat- 
ing the measures to be taken to prevent the spread of the disease. 

Strict isolation shall include the following measures: 



(a) The patient shall have a separate bed in a room protected against 
flies. 

(b) All persons, except those caring for the patient, shall be excluded 
from the sick room. 

(c) The persons caring for the patient shall avoid coming in contact 
with any other persons within the household or elsewhere until every pre- 
caution has been taken to prevent the spread of infectious material from 
the patient's room. 

(d) The persons caring for the patient shall wear a washable outer gar- 
ment and shall thoroughly wash their hands with soap and hot water after 
handling the patient or any object he may have contaminated. On leaving 
the room in which the patient is isolated, the attendant shall take off the 
washable outer garment and hang it in the room until disinfected. 

(e) All discharges from the nose and mouth shall be burned or disin- 
fected. The discharges should be received in pieces of soft tissue or cloth 
and dropped into a paper bag which can be burned. 

(f) Objects which may have been contaminated by the patient shall be 
thoroughly cleansed before being removed from the contaminated area. 

(g) The feces and urine of patients suffering from diseases in which the 
infectious agent appears in the feces or urine shall be disposed of accord- 
ing to instructions given be the local health officer. 

§2518. Modified Isolation. 

If the disease is one in which only a modified isolation is required, the 
local health officer shall issue appropriate instructions, prescribing the 
isolation technique to be followed. The isolation technique will depend 
upon the disease. 

§ 2520. Quarantine. 

Quarantine is defined as the limitation of freedom of movement of per- 
sons or animals that have been exposed to a communicable disease for 
a period of time equal to the longest usual incubation period of the dis- 
ease, in such manner as to prevent effective contact with those not so ex- 
posed. If the disease is one requiring quarantine of the contacts in addi- 
tion to isolation of the case, the local health officer shall determine the 
contacts who are subject to quarantine, specify the place to which they 
shall be quarantined, and issue instructions accordingly. He shall insure 
that provisions are made for the medical observation of such contacts as 
frequently as necessary during the quarantine period. 

§ 2522. Observation. 

For the purposes of definition, the term "observation," as used in these 
regulations, shall refer to a frequent check upon the person under obser- 
vation to determine whether such person is free of the disease for which 
he has been placed under observation, or has contracted the disease. Un- 
less otherwise specified, it does not mean the isolation or quarantine of 
the individual. 

§ 2524. Terminal Disinfection. 

Each person released from quarantine or isolation shall bathe and wash 
his hair with soap and hot water and put on clean clothes. The area of iso- 
lation shall be disinfected according to the instructions of the local health 
officer. 

§ 2526. Exclusion and Readmission by School Authorities. 

It shall be the duty of the principal or other person in charge of any pub- 
lic, private or Sunday School to exclude therefrom any child or other per- 
son affected with a disease presumably communicable, until the expira- 
tion of the prescribed period of isolation for the particular communicable 
disease. If the attending physician, school physician, or health officer 
finds upon examination that the person is not suffering from a communi- 
cable disease, he may submit a certificate to this effect to the school au- 
thority who shall readmit the person. 

NOTE: Authority cited: Sections 207, 208 and 3123. Health and Safety Code. Ref- 
erence: Sections 200, 207, 3051, 3053, 3110, 3118 and 3123, Health and Safety 
Code. 

History 
1. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14). 



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• 



§ 2528. Contamination by Pathogenic Organisms of IVIilk, 
Milk Products or Products Resembling Milk 
Products. 

(a) The Slate Department of Health Services finds that the presence of 
any of the following pathogenic organisms in milk, milk product, or 
product resembling milk products make such product unsafe for human 
consumption: Mycobacterium tuberculosis; Brucella spp.; Streptococ- 
cus pyogenes, group A hemolytic; Corynebacterium diphtheria; Salmo- 
nella paratyphi; Salmonella schottmuelleri; Salmonella hirschfeldi; Sal- 
monella typhi; Salmoneela dublin; Salmonella typhimurium; Shigella 
spp. Whenever a health officer finds that milk, milk product, or product 
resembling milk products, is unsafe for human consumption because it 
contains any of the above named organisms, he shall issue a written order 
to the producer or distributor of the product ( 1 ) summarizing the labora- 
tory findings, and (2) prohibiting the sale or disposal of such milk, milk 
product, or product resembling milk products, except by a method ap- 
proved by him, until such time as he finds the product or products to be 
safe for human consumption. 

(b) Whenever a health officer has evidence that milk, milk product, or 
product resembling milk products has caused human illness or contains 
toxins which make such product unsafe for human consumption, he may 
issue a written order to the producer or distributor of the product ( 1 ) stat- 
ing the facts upon which his conclusions are based, and (2) prohibiting 
the use, sale, or disposal of such milk, milk product, or product resem- 
bling milk products, except by a method approved by him, until such time 
as he finds it to be safe for human consumption. 

(c) The health officer shall immediately forward a copy of any order 
issued pursuant to this section to the State Director of Health Services. 

(d) Any producer or distributor of milk, milk product, or product re- 
sembling milk products, subject to an order of a health officer pursuant 
to this section may appeal to the State Department of Health Services 
solely upon the question of whether such products are, in fact, safe for hu- 
man consumption. Such appeal shall be made in writing, stating which 
of the facts set forth in the order are admitted and denied. Upon receipt 
of the written appeal, the State Director of Health Services, after such in- 
vestigation of the matter as he deems necessary, may amend or rescind 
the order, or set the matter for hearing before a hearing officer designated 
by him. In the event the order is not rescinded or amended to the satisfac- 
tion of the appellant, the matter shall be set for hearing. The hearing shall, 
if possible, be set within 14 days from the date of receipt of the appeal, 
unless additional time is required by the appellant. Insofar as is practica- 
ble, the procedures of the Administrative Procedure Act (Ch. 5, Pt. 1 , Div. 
3, Title 2, of the Government Code) shall apply. The hearing officer shall 
submit a proposed decision to the State Department of Health Services 
which shall issue its decision in accordance with Section 1 1 5 1 7 of the Ad- 
ministrative Procedure Act. The decision shall be subject to judicial re- 
view. 

(e) The procedures of this section authorize a health officer to take im- 
mediate action to protect the public health in the event he finds that milk, 
milk products, or products resembling mifk products constitutes the ap- 
plicability of other provisions of law pertaining to the regulation of such 



products, including but not limited to, the provisions of the Agricultural 
Code and the California Pure Foods Act (Ch. 3, Div. 2 1 , Health and Safe- 
ty Code). 

NOTE: Authority cited: Sections 102 and 208. Health and Safety Code. Reference: 
Sections 3 11 0-3 125, Health and Safety Code. 

History 
1. Repealer and new section filed 12-22-69; effective thirtieth day thereafter 
(Register69, No. 52). 

§ 2530. Public Food Handlers. 

No person known to be infected with a communicable disease or sus- 
pected of being infected with a communicable disease shall engage in the 
commercial handling of food, or be employed on a dairy or on premises 
handling milk or milk products, until he is determined by the health offi- 
cer to be free of such disease, or incapable of transmitting the infection. 
(See Chapter 7, Article 1, Section 28295, Health and Safety Code.) 
NOTE: Authority cited: Sections 207, 208 and 3 1 23, Health and Safety Code. Ref- 
erence: Sections 200, 207, 305 1 , 3053, 3110, 3 123. 3131,31 32 and 28295. Health 
and Safety Code 

History 

1. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14). 

§ 2534. Laboratory Tests for the Release of Cases of 
Carriers of Communicable Diseases. 

Whenever laboratory tests are required for the release of cases or carri- 
ers, the tests shall be taken by the health officer or his representatives and 
shall be submitted to a public health officer or his representatives and 
shall be submitted to a public health laboratory approved by the State De- 
partment of Health Services. Specimens may be sent to laboratories not 
so approved, provided the specimens are divided and a portion of the 
specimens are sent to an approved laboratory. Release shall be consid- 
ered on the basis of the report of the approved laboratory only. 

§ 2536. Transportation of Communicable Disease Cases. 

No person with a communicable disease subject to isolation not any 
contact subject to quarantine shall travel or be transported from one place 
to another within the local health jurisdiction, without the permissions of 
the local health officer, and no such person shall travel or be transported 
outside the area of jurisdiction of the health officer until the permission 
of the health officer into whose jurisdiction the patient is to be brought 
is obtained. An exception may be made in instances where the patient is 
to be admitted directly to a hospital for the treatment of the communica- 
ble disease,provided that the health officer from whose jurisdiction the 
case to be transported shall insure that adequate precautions are taken to 
prevent dissemination of the disease by the patient or his contacts en 
route to the hospital. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55. 

No. 8). 

§ 2538. Funerals. 

Funeral services for individuals who have died of a communicable dis- 
ease shall be conducted in accordance with instructions of the health offi- 
cer. In diseases requiring quarantine of contacts, a public funeral service 
may be permitted only if the casket remains closed and those contacts 



• 



[The next page is 67.] 



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§2560 



• 



subject to quarantine who attend the funeral are adequately segregated 
from the public. 

§ 2540. General Clause. 

In addition to the requirements stipulated in these regulations, the local 
health officer shall, after suitable investigation, take such additional steps 
as he deems necessary to prevent the spread of communicable disease or 
a disease suspected of being communicable in order to protect the public 
health. 



Article 3. Specific Diseases and Conditions 

§ 2550. Amebiasis. 

(a) Under ordinary circumstances, isolation of cases and quarantine of 
contacts are not required. 

(b) Persons who are found to be excreting Endamoeba histolytica in 
the feces shall be prohibited from public food handling until three feces 
specimens, taken at intervals of not less than three days, shall be proved 
negative for the organism by a public health laboratory approved by the 
State Department of Health Services. 

§ 2551. Anthrax. Cases and Suspect Cases to Be Reported 
by Telephone. 

(See Section 2502(c).) 

(a) Patient. The patient shall be isolated in accordance with Section 
25 1 8. Wound isolation precautions shall be instituted until lesions are 
free of anthrax bacilli. There are no restrictions on contacts. 

(b) Laboratory. Whenever a laboratory receives a specimen for the 
laboratory diagnosis of suspected human anthrax, such laboratory shall 
communicate immediately by telephone with the Microbial Diseases 
Laboratory of the State Department of Health Services for instruction. 
Note: Authority cited: Sections 100180, 100275, 120L30and 120145, Health and 
Safety Code. Reference: Sections 120130, 120175, 120190, 120195 and 120215, 
Health and Safety Code. 

History 

1 . Amendment of section heading and section and new Note filed 1 1-5-2001 as 
an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A Certificate of 
Compliance must be transmitted to OAL by 3-5-2002 or emergency language 
wiU be repealed by operation of law on the following day. 

2. Amendment of section heading and section and new Note refiled 3-1-2002 as 
an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of 
Compliance must be transmitted to OAL by 7-1-2002 or emergency language 
will be repealed by operation of law on the following day. 

3. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 
and filed 7-16-2002 (Register 2002, No. 29). 

§ 2552. Botulism. Cases and Suspect Cases to Be 
Reported by Telephone. 

(See Section 2502(c).) The health officer shall make an immediate in- 
vestigation of every case or suspected case of botulism in an effort to es- 
tablish the diagnosis and determine the source. In the event that a com- 
mercial food product is suspected as the source, special instructions will 
be given by the State Department of Health Services. The local health of- 
ficer shall take all necessary steps to prevent distribution and consump- 
tion of the suspected food. There are no restrictions on case or contacts. 
Whenever a laboratory receives a specimen for the laboratory diagnosis 
of suspected human botuUsm, such laboratory shall communicate im- 
mediately by telephone with the Microbial Diseases Laboratory of the 
Department of Health Services for instruction. 

Note: Authority cited: Sections 100180, 100275 and 120130, Health and Safety 
Code. Reference: Sections 100180, 100275, 120175, 120185 and 120190, Health 
and Safety Code. 

History 

1 . Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

2. Amendment of secUon heading and section and new Note filed 1 1-5-2001 as 
an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A Certificate of 
Compliance must be transmitted to OAL by 3-5-2002 or emergency language 
will be repealed by operation of law on the following day. 

3. Amendment of section heading and section and new Note refiled 3-1-2002 as 
an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of 



Compliance must be transmitted to OAL by 7-1-2002 or emergency language 
will be repealed by operation of law on the following day. 
4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 
and filed 7-16-2002 (Register 2002, No. 29). 

§ 2553. Brucellosis (Undulant Fever). Cases and Suspect 
Cases to Be Reported by Telephone. 

(See Section 2502(c).) There are no restrictions on case or contacts. 
Whenever a laboratory receives a specimen for the laboratory diagnosis 
of suspected human brucellosis, such laboratory shall communicate im- 
mediately by telephone with the Microbial Diseases Laboratory of the 
Department of Health Services for instruction. 

NOTE: Authority cited: Sections 100180, 100275 and 120130. Health and Safety 
Code. Reference: Sections 100180, 100275, 120185 and 120190, Health and Safe- 
ty Code. 

History 

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

2. Amendment of section heading and section and new Note filed 1 1-5-2001 as 
an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A Certificate of 
Compliance must be transmitted to OAL by 3-5-2002 or emergency language 
will be repealed by operation of law on the following day. 

3. Amendment of secdon heading and section and new Note refiled 3-1-2002 as 
an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of 
Compliance must be transmitted to OAL by 7-1-2002 or emergency language 
will be repealed by operation of law on the following day. 

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 
and filed 7-16-2002 (Register 2002, No. 29). 

§ 2554. Chancroid. 

(See Section 2636 on Venereal Diseases.) 

§ 2555. Chickenpox. 

History 
1. Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8). 

§ 2556. Cholera. Cases and Suspect Cases to Be Reported 
by Telephone or Telegraph. 

(See Section 2501(c).) The case shall be isolated in accordance with 
Section 25 1 6 and the intimate contacts quarantined pending receipt of in- 
structions from the State Health Services Department. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 

8). 

§ 2558. Coccidioidomycosis. 

Report active cases only primary (including cavitary) or disseminated. 
There are no restrictions on case or contacts. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 

8). 

§ 2560. Conjunctivitis, Acute Infectious of the Newborn. 

(a) Acute infectious conjunctivitis of the newborn includes gonorrheal 
ophthalmia and ophthalmia neonatorum. 

(b) Prophylaxis for acute infectious conjunctivitis of the newborn shall 
be administered to all infants within two hours after birth in accordance 
with Sections 551-556 of the Business and Professions Code. 

(c) The approved prophylaxis for acute infectious conjunctivitis of the 
newborn shall be any one of the following. 

( 1 ) One percent silver nitrate in wax ampules administered without sa- 
line irrigation. 

(2) Ophthalmic ointments or drops containing tetracycline or erythro- 
mycin. 

(d) An infant with acute infectious conjunctivitis shall be isolated in 
accordance with Section 25 16, Title 1 7, California Administrative Code, 
until clinical recovery occurs and negative laboratory tests are obtained. 
NotE: Authority cited: Section 555(b), Business and Professions Code. Refer- 
ence: Sections 551 through 556, Business and Professions Code. 

History 

1. Amendment filed 5-28-53; effective thirt^ieth day thereafter (Register 53, No. 
9). 

2. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 
20). 



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§2562 



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Title 17 



3. Amendment filed 12-15-79; effective thirtieth day thereafter (Resister 79, No. 
50). 

§ 2562. Dengue. Cases and Suspect Cases to Be Reported 
by Telephone or Telegraph. 

(See Section 2501(c).) The case shall be confined during the clinical 
phase of the disease in a room or dwelling satisfactorily protected against 
mosquitos. There are no restrictions on contacts. 

History 
1 . Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 

8). 

§ 2564. Diarrhea of the Newborn. 

(a) Any infant under 1 month of age in a hospital or institution, or any 
infant hospitalized because of prematurity, who has two or more watery 
or otherwise apparently abnormal stools within a 24-hour period, with 
or without other signs of illness, shall be considered a suspicious case of 
diarrhea of the newborn and immediately isolated. Any newborn, who 
within four days after discharge from a hospital has two or more watery 
or otherwise apparently abnormal stools within a 24-hour period, with 
or without other signs of illness, shall be considered a suspicious case and 
kept under close observation. If the diarrhea continues for more than two 
days the infant shall be immediately reported as a case of diarrhea of the 
newborn to the local health officer by telephone or other equally prompt 
means. An exception may be made in the case of entirely breastfed in- 
fants who show no signs of illness and are gaining weight. 

(b) Isolation of Case. The case shall be placed in strict isolation until 
discharged from the hospital. 

(c) Quarantine of Infants in Nursery. If two or more cases occur, all 
infants in the nursery shall be quarantined and no infants shall be ad- 
mitted until all exposed infants have been discharged and the nursery 
thoroughly cleaned, and personnel, equipment, and procedures involved 
have been investigated by the health officer and found adequate. 

(d) Care of Noncontacts. Infants bom subsequent to quarantine of in- 
fants in the newborn nursery for diarrhea of the newborn shall be cared 
for in a separate clean newborn nursery by a separate nursing staff. 

(e) Closure of Hospital to Maternity Admissions. If cases of diarrhea 
of the newborn as defined above occur also in the temporary clean nurs- 
ery, the hospital shall be closed to maternity admissions until all cases 
and contacts are discharged and all nursery rooms and equipment thor- 
oughly cleaned. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 



§ 2566. Diphtheria. 

(a) Isolation of Patient. The patient shall be isolated in accordance with 
Section 2516 until 2 cultures from the throat and 2 from the nose, taken 
not less than 24 hours apart, fail to show the presence of diphtheria bacilli, 
except that upon clinical recovery and where antibiotics have been used 
as therapy, isolation may be modified in accordance with Section 2518. 
Release cultures may not be taken less than seven days after discontinu- 
ance of such therapy. Isolation may be terminated if the bacilli cultured 
from the case are proved to be virulent. 

(b) Control of Household Contacts. All household contacts shall be 
kept under daily medical observation for clinical evidence of diphtheria 
for seven days after last exposure. These contacts shall be isolated if they 
are found to have sore throat or nasal discharge until proved by culture 
not to have diphtheria. All household contacts under the age of 1 5 shall 
be quarantined for at least seven days after the last exposure to the case. 
Nose and throat cultures for diphtheria should then be taken and the con- 
tacts may be released from quarantine if such cultures are negative. If the 
contact has received an antibiotic, release cultures may not be taken less 
than seven days after discontinuation of such medication. 

(c) Release of Carriers From Isolation. Convalescent or healthy carri- 
ers of diphtheria bacilli may be released from quarantine if the bacilli are 
shown to be avirulent by appropriate laboratory tests. Any person who 



has been free from the symptoms of diphtheria for four weeks or longer 
and who harbors virulent diphtheria bacilli is defined as a chronic carrier. 
Efforts should be made to eliminate the carrier state in such persons by 
appropriate medical or surgical measures. If these measures are un- 
successful or are refused the health officer may release the carrier from 
isolation when, in his judgment, such release is not detrimental to the 
public health, except that the carrier may not be permitted to engage in 
any occupation which involves handling of foods of close association 
with children outside his own family. 

(d) Laboratory Tests for the Release of Cases or Carriers. Cultures or 
virulence tests for the release of diphtheria cases or carriers shall be taken 
not less than seven days after discontinuation of antibiotic therapy and 
examined in accordance with the provisions of Section 2534. 

(e) Cases on Dairies. When a case of diphtheria occurs or is confined 
on the premises where milk or milk products are handled, the health offi- 
cer shall prohibit the use, sale or disposal of such milk or milk product, 
except by a method approved by him, until he is satisfied that such prod- 
ucts are safe for human consumption. 

(f) Immunization. The health officer shall take appropriate measures 
to encourage and facilitate a continuing program of active immunization 
against diphtheria for all children within his jurisdiction. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

§ 2570. Encephalitis, Acute (Including Arthropod-Borne 
Viral, Post-Infectious, and Others). 

The patient shall be isolated in accordance with Section 25 1 8 for seven 
days from the onset of the infection. There are no restrictions on contacts. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 

8). 

§ 2572. Disorders Characterized by Lapses of 

Consciousness, Alzheimer's Disease and 
Related Disorders. 

NOTE: Authority cited: Sections 100275 and 103900, Health and Safety Code. 
Reference: Section 103900, Health and Safety Code. 

History 

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No. 
20). 

2. Amendment filed 1 1-9-66; effective thirtieth day thereafter (Register 66, No. 
39). 

3. Amendment of subsection (a) and new subsections (b)-(d) filed 1-9-90; opera- 
tive 1-9-90 pursuant to Government Code Secfion 11346.2(d) (Register 90, 

No. 4). 

4. Repealer of section and amendment of Note filed 5-17-2000; operadve 
10-2-2000 (Register 2000, No. 20). 

§ 2574. Food Poisoning. 

(Excluding Botulism and Salmonella infections). A reportable case of 
food poisoning is defined as follows: any person with symptoms of acute 
gastroenteritis, vomiting, diarrhea, or neurologic symptoms whose ill- 
ness occurs in association with a group of other persons who may have 
consumed a common food or beverage. The etiologic agents include: 

(a) Organic poisons present in normal animal or plant tissues, includ- 
ing mushrooms, fish, and mussels. 

(b) Mineral or organic poisons, including arsenic, lead, cadmium, and 
fluorine, introduced into food by accident, or with the intent to improve 
the appearance or as preservatives. 

(c) Toxins preformed in food by the growth of microorganisms, in- 
cluding staphylococci. (Botulism is reported separately. See Section 
2552.) 

Upon receiving the report, the health officer shall make or cause to be 
made an investigation in an effort to determine the source and cause of 
the outbreak. If the responsible food is one distributed outside the area 
over which he has jurisdiction, he shall immediately report his findings 
to the Director of the State Department of Health Services and to those 
local health officers concerned. There are no restrictions on cases or con- 
tacts. 



• 



Page 68 



Register 2002, No. 29; 7-19-2002 



Title 17 



State Department of Health Services 



{} 2593 



§ 2575. German Measles (Rubella). 

The patient shall be isolated in accordance with Section 2518 until 
clinically recovered. There are no restrictions on contacts. 

History 

1 . Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55. No. 8). 

2. New section filed 10-25-66; effective thirtieth day thereafter Register 66, No. 
.17). For history of former section see Register 55. No. 8. 

§ 2577. Gonococcus Infection. 

(See Section 2636 on Venereal Diseases.) 

§ 2578. Granuloma Inguinale. 

(See Section 2636 on Venereal Diseases.) 

§ 2579. Hepatitis, Infectious. 

(This term includes cases diagnosed as acute catarrhal jaundice, epi- 
demic hepatitis and epidemic jaundice.) The patient shall be isolated in 
accordance with Section 2518 during the acute symptoms. There are no 
restrictions on contacts. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 

8). 

§ 2580. Influenza, Epidemic. 

History 
1. Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8). 

§ 2581. Hepatitis, Serum (Homologous Serum Jaundice). 

The patient shall be isolated in accordance with Section 2518 during 
the acute symptoms. There are no restrictions on contacts. 

History 
1. New section filed 5-24—55; effective thirtieth day thereafter (Register 55, No. 

8). 

§ 2582. Leprosy (Hansen's Disease). 

The patient shall be isolated in accordance with Section 2518 if deter- 
mined by clinical observation or by laboratory findings to be infectious. 
The degree of isolation shall be determined by the local health officer, 
who should, whenever possible, be advised by a physician specially qual- 
ified in this disease. If isolation of the patient is required and cannot be 
carried out at home or if adequate therapy is not available, the State De- 
partment of PubHc Health shall be notified and shall designate a hospital 
where the patient shall be isolated and treated. Apparently arrested or in- 
active cases, and persons who have been in close contact with a case for 
a prolonged period, shall be kept under observation as long as deemed 
necessary by the local health officer to determine if they have become in- 
fected or the disease reactivated. 

All reports pertaining to cases of leprosy are confidential and the iden- 
tity of patients shall not be divulged except as may be necessary for the 
protection of the public health. 

History 

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

2. Amendment filed 7-19-55, as an emergency; effective upon filing (Register 55, 
No. 10). 

§ 2584. Leptospirosis (Including Weil's Disease). 

There are no restrictions on case or contacts. 
History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

§ 2585. Lymphogranuloma Venereum. 

(See Secfion 2636 on Venereal Diseases.) 

§ 2586. Malaria. 

The pafient shall be confined during the chnical phases of the disease 
in a room or dwelling satisfactorily protected against mosquitoes. 

§ 2588. Measles. 

The patient shall be isolated in accordance with Section 2518 during 
the period of catarrhal symptoms and for seven days after the appearance 



of the rash. Restriction on contacts is not required, except at the discretion 
of the local health officer. 

§ 2590. Meningitis, Meningococcal or Menlngococcemia. 

(a) The patient shall be isolated in accordance with Section 25 1 8 until 
the end of the febrile period and until all acute symptoms have subsided. 

(b) Contacts. Quarantine of contacts is not required, except at the dis- 
cretion of the local health officer, but intimate contacts should be kept un- 
der frequent medical observation for a minimum of three days subse- 
quent to diagnosis of the case. Prophylactic treatment of household 
contacts under medical supervision may be required by the health officer 
prior to release. 

History 
1. Amendment filed 5-24-55; effective thirtieth dav thereafter (Register 55. No. 
8). 

§ 2592. Mumps. 

The patient shall be isolated in accordance with Section 25 18 until the 
swelling of the salivary glands has subsided. There are no restrictions on 
contacts. 

History 

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

§ 2593. Neoplasm, Cancer. 

(a) Definifions. 

(1) Department means Department of Health Services. 

(2) Director means the Director of the Department of Health Services. 

(3) Regional cancer registry means the organization authorized to re- 
ceive and collect cancer data for a designated area of the state and which 
maintains the system by which the collected information is reported to 
the Department. 

(4) Cancer means all malignant neoplasms, including carcinoa in situ, 
which are specified in Volume I of the 1 986 California Cancer Reporting 
System Standards and as set forth in the International Classification of 
Diseases for Oncology Field Trial Edition 1986. 

(5) Case means a cancer diagnosis for an individual who is either a res- 
ident of the designated area of the regional cancer registry, regardless of 
where the individual was treated or diagnosed, or seen at a cancer report- 
ing facility, other facility or by a physician within the designated area of 
the regional cancer registry, regardless of where the individual resides. 

(6) Active follow-up program means a system for determining the vi- 
tal status of each reported case no later than twelve months after the date 
of the last reported contact. This date is defined in Volume I of the 1 986 
California Cancer Reporting System Standards. 

(7) Cancer reporting facility means a hospital or other facility which 
treats or diagnoses cancer and is also one of the following: 

(A) A facility currently licensed as a health facility under the provi- 
sions of Chapter 2, commencing with Section 1250, of Division 2 of the 
Health and Safety Code; 

(B) A surgical clinic licensed under Chapter 1, Section 1204, of Divi- 
sion 2 of the Health and Safety Code; 

(C) A facility covered by the provisions of Section 1206, except for 
subsection (f), of the Health and Safety Code which, while not licensed 
as a clinic, is operated for the predominant purpose of diagnosing or treat- 
ing cancer or where a minimum of 1 00 or more cancer cases are diag- 
nosed or treated in a year. 

(8) Quality Control System means operational procedures by which 
the accuracy, completeness and timeliness of the information reported to 
the Department can be determined and verified. These criteria are de- 
fined in Volume I of the 1986 California Cancer Reporting System Stan- 
dards. 

(9) Certified Tumor Registrar (CTR) means the designation given to 
individuals who pass the certification examination given by the National 
Tumor Registrars Association (NTRA). 

(10) Population-based means that all cases are drawn from a defined 
population of known size and characteristics, usually one within a de- 
fined geographic area. 



Page 69 



Register 2002, No. 29; 7-19-2002 



§2593 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(11) Cancer incidence data means information on new cases of cancer 
including the required data listed in the 1 986 California Cancer Report- 
ing System Standards and counts of these cases by their characteristics 
such as age, sex and ethnicity, and by anatomic site and morphology. 

(12) Instance of cancer means case of cancer as defined in subsection 
(a)(5) above. 

(13) Modeled after the Cancer Surveillance Program of Orange 
County means a population-based registry that collects treatment data, 
has a phased implementation, collects follow-up data, has a community 
advisory component and receives data in a machine-readable format 
from cancer reporting facilities as defined in subsection (a)(7) above. 

(b) Reporting requirements. The Director shall designate cancer as a 
disease to be mandatorily reported for all counties within the State. All 
counties shall be assigned to a designated regional cancer registry. When 
the Director designates cancer as a disease to be mandatorily reported 
within an area, the Director shall designate the initial mandatory report- 
ing period, which may be less than a full calendar year, for which the re- 
gional registry will submit cases to the Department. 

(DA regional cancer registry shall establish and maintain a cancer re- 
porting system which is able to report 97 percent of the incident cases in 
the initial designated reporting period and each calendar year. 

(2) The regional cancer registry shall have suitable arrangements to 
obtain data for reporting resident cases diagnosed or treated outside the 
designated area of the regional cancer registry. 

(3) The regional cancer registry shall report to the Department all cases 
diagnosed or treated in a calendar year or initial reporting period within 
twelve months after the close of that calendar year or initial reporting pe- 
riod. 

(4) The regional cancer registry shall submit, for each reportable case, 
the required data specified in Volume I, Section 13, of the 1986 Califor- 
nia Cancer Reporting System Standards. 

(5) The regional cancer registry shall report to the Department all 
follow-up information provided by cancer reporting facilities with an ac- 
tive follow-up program no later than six months after the cancer report- 
ing facility provides the information to the regional registry. In addition, 
each regional registry shall implement within three years of the designa- 
tion of mandatory cancer reporting for the region a program of active 
follow-up for all resident cases not otherwise being followed by a cancer 
reporting facility. The results of the active follow-up program of the re- 
gional registry shall be reported to the Department quarterly. 

(6) Data submitted to the Department by the regional cancer registry 
shall be in machine-readable form. The format and codes used shall be 



as specified by the Department. 

(7) The regional cancer registry shall maintain a system of quality con- 
trol in accordance with procedures approved by the Department. 

(8) Representatives of the Department shall have access to the source 
data and the stored data in the regional cancer registry for the purpose of 
quality control assessments. This includes access to all cancer records 
maintained by a reporting facility, physician, individual or agency pro- 
viding diagnostic or treatment services to cancer patients within the re- 
gion. 

(9) The regional cancer registry shall maintain confidentiality of data 
as required in Section 2 1 1 .5, Health and Safety Code, and shall maintain 
a security system for records which contain identifying data. This system 
shall be reviewed and approved by the Department. 

(10) When cancer is designated a reportable disease in a region, the 
corresponding regional cancer registry shall inform the public that cancer 
has been designated as a disease required to be reported in that region and 
that each patient diagnosed or treated with a Reportable Neoplasm will 
be reported to the Department as required by law. 

(11) Cancer reporting facilities within a reporting region shall report 
to the regional cancer registry the required data as listed in Volumes I and 
III of the 1986 California Cancer Reporting System Standards. These re- 
ports shall conform to Volumes I, II and III of the 1986 California Cancer 
Reporting System Standards. When a cancer reporting facility fails to 
produce reports meeting the standards cited above, the regional cancer 
registry may perform the data collection and collect compensation from 
the facility for the activity at cost. 

(12) Cancer reporting facilities shall report to their regional cancer 
registry each reportable case within six months of the time the case comes 
under the care of, or is admitted to, the facility. 

(13) Cancer reporting facilities with an active follow-up program 
shall report follow-up information to the regional cancer registry no less 
frequently than quarterly. 

(14) A facility not already defined as a cancer reporting facility under 
these regulations which diagnoses or treats cancer and is a primary care 
clinic as defined in Section 1 204, Health and Safety Code or an acute psy- 
chiatric hospital as defined in Section 1 250, Health and Safety Code shall 
report each cancer case to its regional cancer registry, or to the local 
health department, the choice to be determined by the regional registry, 
using the Confidential Morbidity Report (Form PM-1 10), shown below, 
within 30 days of the date the patient is admitted to the facility or treated 
in the facility for the first time. These reports shall conform to California 
Cancer Reporting System Standards, Volume IV. 



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CONFIDENTIAL MORBIDITY REPORT 

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(15) Physicians and surgeons caring for cancer patients not referred to 
a facility defined as a cancer reporting facility under these regulations 
shall report each cancer case to the regional cancer registry or to the local 
health department, the choice to be determined by the regional registry, 



using the Confidential Morbidity Report (PM-110), within 30 days of 
seeing the patient for the cancer for the first time. These reports shall con- 
form to California Cancer Reporting System Standards, Volume IV. 



Page 70 



Register 2002, No. 29; 7-19-2002 



Title 17 



State Department of Health Services 



§ 2603 



(16) Cancer reporting facilities shall submit their cancer cases and 
follow-up information to the regional cancer registry in machine-read- 
able form. The format and codes used shall be as specified by the Depart- 
ment in the 1986 California Cancer Reporting System Standards Vol- 
ume II. 

( 1 7) Cancer reporting facilities may elect to have the regional cancer 
registry staff do the cancer data collection. They may do so by a contract 
with the regional cancer registry to identify and report the cancer cases 
with the facility reimbursing the regional registry for that registry's ex- 
pense. 

(18) Cancer reporting facilities and physicians shall employ a mecha- 
nism to ensure that their patients are informed that cancer has been desig- 
nated a reportable disease and that the facility will report each patient 
with cancer to the Department as required by law. Patient information 
sheets for this purpose will be supplied to physicians by the Department. 

(c) Staffing. The identification and collection of cancer data in the re- 
gional cancer registries and cancer reporting facilities shall be performed 
by Certified Tumor Registrars (CTR) or staff eligible to take the certifica- 
tion examination. 

(d) Training and Credentialing Period. Reporting facilities so request- 
ing upon application to the regional registry, may be granted a credential- 
ing period of up to 24 months for the purpose of obtaining training to meet 
the requirements set forth in subsection (c) above. No credentialing peri- 
od may be granted to extend beyond 30 months from the effective date 
of mandatory cancer reporting for the region or beyond July 1 , 1 990. Dur- 
ing a credentialing period the reporting facility must meet the quality and 
other reporting standards. It is the responsibility of the Department, 
which may be carried out by the regional cancer registries, to assure that 
adequate tumor registrar training resources are available for no less than 
24 months following the initiation of mandatory reporting in a region. 

(e) Designation of Agent. The Director may designate and contract 
with any agency to act as the Department's agent for the maintenance of 
the regional cancer registry. The designated agent shall comply with all 
regulations for the regional cancer registry. 

(f) Revocation of Designation. The Director shall have the authority 
to revoke the designation as Departmental agent. Revocation shall be ef- 
fective no sooner than 30 days after a written notice to revoke the desig- 
nation has been served. 

NOTE: Authority cited: Sections 208, 2 10 and 2 II .3, Health and Safety Code. Ref- 
erence: Sections 210, 211.3 and 211.5, Health and Safety Code. 

History 

1. New section filed 3-20-81; effective thirtieth day thereafter (Register 81, No. 
12). 

2. Amendment filed 1 1-2-87; operative 12-2-87 (Register 87, No. 45). 

§ 2594. Pertussis (Whooping Cough). 

The patient shall be isolated in accordance with Section 2518 during 
the early catarrhal period and for 21 days after the appearance of the typi- 
cal paroxysmal cough. The isolation provisions shall be adequate to pre- 
vent exposure of young children to the patient. Restrictions on contacts 
not required. 

§ 2595. Physically Handicapped Children 

(See subchapter 3). 

§ 2596. Plague. Cases and Suspect Cases to Be Reported 
by Telephone. 

(See Section 2502(c).) 

(a) All laboratory specimens submitted for the purpose of establishing 
a diagnosis shall be examined only in such laboratories as may be desig- 
nated by the Director of the State Department of Health Services. When- 
ever a laboratory receives a specimen for the laboratory diagnosis of sus- 
pected human plague, such laboratory shall communicate immediately 
by telephone with the State Department of Health Services Microbial 
Diseases Laboratory for instruction. 

(b) Isolation. The patient shall be confined in a dwelling free from ro- 
dents and fleas and shall be isolated in accordance with Section 25 1 6. The 
period of isolation shall not be terminated until two days after all symp- 



toms have subsided. In cases of pneumonic plague, strict precautions 
against respiratory transmission of the disease shall be enforced. 

(c) Contacts. Contacts of cases of plague shall be kept under quaran- 
tine until the health officer is satisfied that they have not contracted the 
infection, except that contacts of cases of pneumonic plague shall be kept 
in quarantine for a period of at least seven days after last exposure. 
NOTE: Authority cited: Sections 100180, 100275, I20I30and 120145. Health and 
SafetvCode. Reference: Sections 100180, 100275, 120145, 120190, 120215 and 
120240. Health and Safety Code. 

History 

1 . Amendment filed 5-24-55; effective thirtieth dav thereafter (Reeister 55, No. 
8). 

2. Amendment of section heading and subsection (a) and new Nori-. filed 
1 1-5-2001 as an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A 
Certificate of Compliance must be transmitted to OAL by 3-5-2002 or emer- 
gency language will be repealed by operation of law on the following day. 

3. Amendment of section heading and subsection (a) and new NoTi. refiled 
3-1-2002 as an emergency; operative 3-1-2002 (Register 2002, No. 9 ). A Cer- 
tificate of Compliance must be transmitted to OAL by 7-1 -2002 or emergency 
language will be repealed by operafion of law on the following day. 

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 
and filed 7-16-2002 (Register 2002, No. 29). 

§2597. Q Fever. 

No restrictions on cases or contacts. 
History 
1. New section filed 5-24-55; effective thirtieth day thereafter (Register 55. No. 
8). 

§ 2598. Pneumonia, Infectious (Except Pneumonic 
Plague). 

History 
I. Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8). 

§ 2600. Poliomyelitis, Acute Anterior. 

The case shall be isolated in accordance with Section 25 1 8 for a period 
of seven days from the onset of illness or for the duration of fever if long- 
er. Restrictions on contacts is not required, except at the discretion of the 
local health officer. 

§ 2602. Psittacosis. 

The patient shall be isolated in accordance with Section 2518 during 
the acute stages. There are no restrictions on contacts. 

§ 2603. Control of Pet Birds. 

(a) The department or local health officers may quarantine any species 
of pet birds imported into this State from states and countries where psit- 
tacosis or other diseases transmitted by pet birds to human beings have 
been reported by an official agency to be currently prevalent in pet birds. 
Such quarantine shall remain in effect until removed by the department, 
or local health officers, following proof that the quarantined birds are not 
infected with psittacosis or other diseases transmissible by pet birds to 
human beings. 

(b) Whenever a pet bird or birds are suspected to be a source of human 
disease or a pet bird or birds are infected with a disease which is a poten- 
tial source of human disease and, in the opinion of the department or local 
health officers, it is deemed necessary for the protection of the public, the 
pet bird or birds shall be quarantined. Such quarantine shall remain in ef- 
fect until the quarantine authority has evidence that the quarantined bird 
or birds are not a hazard to the public's health. Such evidence may be ob- 
tained by the following actions: 

(1) A sufficient number of birds, such numbers to be specified by the 
quarantine authority, are to be provided for laboratory testing in a labora- 
tory approved by the department. 

(2) If, upon completion of the necessary laboratory test no evidence is 
found that the birds are infected with a disease hazardous to human 
health, they may be released from quarantine. Such release shall be made 
only by the quarantine authority. 

(3) If upon completion of the necessary laboratory test there is evi- 
dence that the bird or birds are infected with a disease hazardous to hu- 
man health, the bird or birds shall remain under quarantine until the haz- 
ard has been eliminated to the satisfaction of the quarantine authority. 



Page 71 



Register 2002, No. 29; 7-19-2002 



§ 2603.5 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



(4) If, following treatment methods or other methods which may be 
used to eliminate the hazard in the quarantined bird or birds, the quaran- 
tine authority finds that the hazard to humans no longer exists, it may re- 
lease the bird or birds from quarantine. 

(5) The owner of the quarantined bird or birds shall have the option to 
destroy the quarantined bird or birds if he so desires. In such case the 
quarantine will be lifted following evidence that the infected premises 
are thoroughly disinfected. 

NOTE: Authority cited: Sections 100273 and 121745, Health and Safety Code. 
Reference: Section 121745. Health and Safety Code. 

History 

1. Amendment of subsections (a)(3), (a)(4), (d) and (k) filed 12-15-67; effective 
thirtieth day thereafter (Register 67, No. 50). For prior history, see Register 65, 
No. 22. 

2. Amendments of subsection (d) filed 8-10-70; effective thirtieth day thereafter 
(Register 70, No. 33). 

3. Amendment of subsections (a) and (f) filed 11 -20-85; effective upon filing pur- 
suant to Government Code Section 1 1346.2(d) (Register 85, No. 47). 

4. Change without regulatory effect of NOTE (Register 86, No. 32). 

5. Change without regulatory effect repealing subsections (a)-(/), relettering sub- 
sections, and amending NOTE filed 1-28-99 pursuant to section 100, title 1, Cal- 
ifornia Code of Regulations (Register 99, No. 5). 

§ 2603.5. Control of Psittacine Birds. 

NOTE; Authority cited: Sections 208 and 2100, Health and Safety Code. 

History 

1. New section filed 11-2-55 as an emergency; effective upon filing (Register 
55,No. 16). 

2. Repealer filed 12-1 9-55; effective thirtieth day thereafter (Register 55, No. 1 8). 

§ 2604. Rabies, Human. 

The patient shall be isolated in accordance with Section 2518 during 
the course of the disease. There are no restrictions on contacts of a human 
case. 

NOTE: Authority cited: Sections 102, 208 and 1900-2000, Health and Safety 
Code. 

History 
1. Amendment filed 12-19-57; effective thirtieth day thereafter (Register 57, No. 

22). 

§ 2606. Rabies, Animal. 

(a) Reporting. Any person having knowledge of the whereabouts of an 
animal known to have or suspected of having rabies shall report the facts 
immediately to the local health officer. The health officer shall likewise 
be notified of any person or animal bitten by a rabid or suspected rabid 
animal. 

In those areas declared by the Director of the State Department of 
Health Services to be rabies areas (See Section 1901.2, California Health 
and Safety Code) the local health officer shall be notified when any per- 
son is bitten by an animal of a species subject to rabies, whether or not 
the animal is suspected of having rabies. 

(b) Isolation. Any rabid animal, clinically suspected rabid animal, or 
biting animal shall be isolated in strict confinement as follows: 

(1) Isolation of Rabid Animals or Clinically Suspected Rabid Ani- 
mals. Any rabid animal or clinically suspected rabid animal shall be iso- 
lated in strict confinement under proper care and under the observation 
of a licensed veterinarian, in a pound, veterinary hospital, or other ade- 
quate facility in a manner approved by the local health officer, except 
where such responsibility has been delegated to a comparable officer by 
the governing body, and shall not be killed or released for at least 10 days 
after the onset of symptoms suggestive of rabies, with the exception that 
such animals may be sacrificed with permission of the local health officer 
for the purpose of laboratory examination for rabies using the fluorescent 
rabies antibody (FRA) test in an approved public health laboratory. 

(2) Isolation of Biting Animals. At the discretion of the local health of- 
ficer, any animal which bites or otherwise exposes a person shall be iso- 
lated in strict confinement in a place and manner approved by the local 
health officer and observed for at least 14 days (dogs and cats 10 days) 
after the day of infliction of the bite, with the exception that the following 
altemaUve to the 10 day isolation of dogs and cats is permitted — dogs or 



cats which have been isolated in strict confinement under proper care and 
under observation of a licensed veterinarian, in a pound, veterinary hos- 
pital, or other adequate facility in a manner approved by the local health 
officer, may be released from isolation by the local health officer after 
five days of veterinary observation if upon conducting a thorough physi- 
cal examination on the fifth day or more after infliction of the bite, the 
observing veterinarian certifies that there are no clinical signs or symp- 
toms of any disease. Notwithstanding the foregoing provisions, a local 
health officer may authorize, with permission of the owner and other le- 
gal restrictions permitting, the euthanasia of a biting animal for the pur- 
pose of laboratory examination for rabies using the fluorescent rabies an- 
tibody (FRA) test in an approved public health laboratory. 

(3) Isolation of Biting Animals in Officially Declared Rabies Areas. 
In officially declared rabies areas (see Section 1901 .2, California Health 
and Safety Code) the isolation described in paragraph (2) above shall be 
mandatory for any animal of a species subject to rabies that has bitten or 
otherwise exposed a person, with the exception of rodents (members of 
the order Rodentia) and rabbits and hares (members of the order Lago- 
moi-pha). 

(4) Laboratory Examination of Rabid Animals, Clinically Suspected 
Rabid Animals or Bidng Animals Which Die or Have Been Killed. If any 
rabid animal, clinically suspected rabid animal or biting animal dies or 
has been killed, adequate specimens shall be obtained and examined in 
a public health laboratory approved by the department. No person shall 
destroy or allow to be destroyed the brain of an animal of a species subject 
to rabies that has bitten or otherwise exposed a person before the destruc- 
tion of such brain has been authorized by the local health department; pro- 
vided, however, that the provisions of this paragraph (4) shall not apply 
to rodents (members of the order Rodentia ) and rabbits or hares (mem- 
bers of the order Lagomorpha ). 

(c) Animal Contacts. Any animal of a species subject to rabies which 
has been bitten by a known rabid or suspected rabid animal or has been 
in intimate contact with a rabid or suspected rabid animal shall be quaran- 
tined in a place and manner approved by the local health officer, except 
where such responsibility has been delegated to a comparable officer by 
the local governing body, for a period of six months or destroyed, with 
the exception that the following alternatives are permitted in the case of 
dogs and cats as follows: 

(1 ) If a dog over one year of age has been vaccinated against rabies 
within 36 months but not less than 30 days with a rabies vaccine of a type 
approved by the Department for a maximum immunity duration of at 
least 36 months, the dog may be revaccinated immediately (within 48 
hours) in a manner prescribed by the Department and quarantined in a 
place and manner approved by the local health officer for a period of 30 
days following revaccination. 

(2) If a dog under one year of age has been vaccinated against rabies 
within 1 2 months but not less than 30 days with a rabies vaccine of a type 
approved by the Department, the dog may be revaccinated immediately 
(within 48 hours) in a manner prescribed by the Department and quaran- 
tined in a place and a manner approved by the local health officer for a 
period of 30 days. 

(3) If a cat has been vaccinated within one year but not less than 30 
days with an annual type feline rabies vaccine or if a cat has been vacci- 
nated under one year of age with a 36-month type of feline rabies vaccine 
within 12 months but not less than 30 days, the cat may be revaccinated 
immediately (within 48 hours) in a manner prescribed by the Department 
and quarantined in a place and manner approved by the local health offi- 
cer for a period of 30 days following revaccination. 

(4) If a cat over one year of age has been vaccinated against rabies and 
has been vaccinated within 36 months and more than 30 days with a 
36-month type feline rabies vaccine, the cat may be revaccinated imme- 
diately (within 48 hours) in a manner prescribed by the Department and 
quarantined in a place and manner approved by a local health officer for 
a 30-day period following revaccination. 



Page 72 



Register 2002, No. 29; 7-19-2002 



Title 17 



State Department of Health Services 



§ 2606.6 



NOTI-;; Authority cited: Sections 208. 1905 and 3123, Health and Safety Code. 
Reference: Sections 1901. 1903. 1903. 1907 and 3123, Health and Safety Code. 

History 

1. Amendment filed 5-5-71; effective thirtieth day thereafter (Register 71, No. 
19). For prior history see Register 65. No. 8. 

2. Amendment of subsection (c) filed 5-20-77; effective thirtieth day thereafter 
(Regi.ster77. No. 21). 

3. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No. 

5). 

§ 2606.2. Rabies Quarantine. 

If rabies i.s knov/n to exist within an area, the local health officer may 
establish a rabies quarantine and shall define the boundaries of the quar- 
antine area and specify the animals subject to quarantine, and all such ani- 
mals within the quarantined area shall be kept in strict confinement upon 
the private premises of the owner, keeper or harborer at all times until the 
quarantine is terminated by the local health officer. 
NOTE: Authority cited: Sections 102, 208 and 1900-2000, Health and Safety 
Code. 

History 

1 . New section filed 1 2-19-57; effective thirtieth day thereafter (Register 57, No. 
22). 

2. Amendment filed 5-5-71; effective thirtieth day thereafter (Register 71, No. 
19). 

§ 2606.4. Officially Declared Rabies Areas. 

(a) Administration and Enforcement. For purposes of administration 
and enforcement of Section 1920, California Health and Safety Code, in 
officially declared rabies areas, the following shall apply: 

( 1 ) Licensing and Vaccination Procedure. The vaccination of dogs 
four months of age or older as required by subdivision (b), Section 1920, 
California Health and Safety Code, shall be held a requisite to licensing 
as required under subdivision (a) therein. Completion of the licensing 
procedure consists of issuance of a license tag or a vaccination tag bear- 
ing the license data and shall be carried out only after presentation of a 
current valid official vaccination certificate. Current copies of the Com- 
pendium of Canine Rabies Vaccines approved by the Department, to- 
gether with the maximum immunity duration periods prescribed by the 
Department for each type product, are available upon request from the 
Veterinary Public Health Unit, Infectious Disease Section, California 
Department of Health Services, 2151 Berkeley Way, Berkeley, Califor- 
nia, 94704, telephone (415) 540-2391. 

(2) Vaccination Certificates. Official vaccination certificates must 
show: 

(A) the name, address and telephone number of the dog's owner; 

(B) the description of the dog, including breed, color, age, and sex; 

(C) the date of immunization; 

(D) the type of rabies vaccine administered; 

(E) the name of the manufacturer; and 

(F) the lot number of the vaccine used. 

Such certificates shall bear the signature of the veterinarian adminis- 
tering the vaccine or a signature authorized by him, and in addition such 
certificate shall be stamped, printed, or typed with his name, address and 
telephone number for legibility, with the exception that at dog vaccina- 
tion clinics conducted pursuant to Section 1 920(f) of the Health and Safe- 
ty Code, vaccination certificates approved by the local health officer may 
be used provided that the specific clinic is identified upon the vaccination 
certificate and records are maintained containing the information speci- 
fied under items (E) and (F) above. 

(3) Interval Permitted for Procurement of License. The vaccination of 
dogs four months of age against rabies as required under subdivision (b). 
Section 1920, California Health and Safety Code, and the license re- 
quired by subdivision (a) of said section shall be procured not later than 
30 days after the dog attains the age of four inonths. The license renewal 
shall be procured not later than 60 days after expiration of the previously 
issued license. 

(4) Rabies Control Activities Reporting. During such time as a county 
is under official declaration as a rabies area, each local official responsi- 



ble for the various phases of local dog or rabies control within each city, 
county and city or cities, or county shall make quarterly rabies control ac- 
tivities reports to and on forms furnished by the Department. Such reports 
shall be submitted to the Department by the local officials responsible for 
the various phases of local dog or rabies control through the local health 
officer so as to reach the Department not later than 30 days following 
each quarter. 

(b) Vaccination of Dogs Against Rabies. Dogs shall be considered to 
be properly vaccinated for the purposes of Section 1920, California 
Health and Safety Code, when injected at four months of age or older 
with an approved canine rabies vaccine and rcvaccinated in accordance 
with the following conditions: 

(1) Primary Immunization. Primary immunization shall be defined as 
the initial inoculation of an approved canine rabies vaccine administered 
to young dogs between the ages of 4 to 12 months. 

(2) Minimum Age for Rabies Vaccination. The minimum age for 
which rabies immunization of dogs shall be accepted for purposes of 
dog-owner compliance with requirements for rabies vaccination and for 
purposes of issuance of dog licenses (See Section 2606.4(a)(1)) is 4 
months. 

(3) Revaccination Intervals. Dogs shall be rcvaccinated one year (12 
months) after the primary immunization with an approved type of rabies 
vaccine. Dogs receiving vaccination after primary immunization or any 
dog receiving its initial rabies vaccination over 12 months of age shall be 
re vaccinated thereafter at least once every three years (36 months) with 
an approved type rabies vaccine. 

(c) Issuance of Dog Licenses. In no instances shall a dog license be is- 
sued for a period beyond the date upon which revaccination is due except, 
following primary immunization in a local jurisdiction which is on a 
fixed one-year licensing period, a license may be issued for a period be- 
yond the revaccination date if early revaccination cannot be required in 
accordance with subdivision (d). 

(d) Notwithstanding the rabies revaccination intervals specified in 
Section 2606.4(b)(3) above, local authorities may require revaccination 
prior to issuance of a license provided that revaccination against rabies 
in no instance shall be required sooner than one year ( 1 2 months) follow- 
ing a primary immunization or sooner than 2 years (24 months) following 
a vaccination of dogs vaccinated over one year (12 months) of age. 
NOTE: Authority cited: Sections 208 and 1905. Health and Safety Code. Refer- 
ence: Sections 1905 and 1920, Health and Safety Code. 

History 

1. New section filed 12-19-57; effective thirtieth day thereafter (Regi.stcr 57, No. 

22). 

2. Amendment filed 5-5-71; effective thirtieth day thereafter (Register 71, No. 
19). 

3. Amendment filed 5-20-77; effective thirtieth day thereafter (Register 77, No. 

21). 

4. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No. 

5). 

§ 2606.6. Importation of Dogs. 

All dogs four months of age or older imported into this State for any 
purpose shall be accompanied by a certificate issued by a licensed veteri- 
narian, stating that the dog or dogs have been vaccinated against rabies 
within 30 months of the date of importation for dogs vaccinated over 1 2 
months of age or within 12 months for dogs vaccinated under 12 months 
of age with a canine rabies vaccine of a type approved by the Department 
for an immunity duration of at least 36 months. 

NOTE: Authority cited: Sections 208 and 1905, Health and Safety Code. Refer- 
ence: Sections 1905 and 1920(b), Health and Safety Code. 

History 

1 . New Section filed 12-19-57; effective thirtieth day thereafter (Register 57. No. 

22). 

2. Amendment filed 5-5-71; effective thirtieth dav thereafter (Register 71, No. 
19). 

3. Amendment filed 5-20-77; effective thirtieth day thereafter (Register 77, No. 
21). 

4. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No. 
5). 



Page 73 



Register 2002, No. 29; 7-19-2002 



§ 2606.8 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



§ 2606.8. Skunk Rabies. 

(a) Due to the presence of rabies in skunks in California and in many 
other states and the resultant hazard to the public health of rabies devel- 
oping in skunks kept as pets, no person shall: 

( 1 ) trap or capture skunks for pets. 

(2) trap, capture or hold skunks in captivity for sale, barter, exchange 
or gift, 

(3) transport skunks from or into the state except as provided under (b) 
below. 

(b) The importation of skunks into (California or the exportation of 
skunks from the State is prohibited except by permit from the California 
State Department of Health Services to a recognized zoological garden 
or a research institution. 

NOTE: Authority cited: Sections 208 and 1905, Health and Safety Code. Refer- 
ence: Section 1905, Health and Safety Code. 

History 

1. New section filed 10-1-62; effective thirtieth day thereafter (Register 62, No. 
21). 

2. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No. 

5). 

§ 2608. Relapsing Fever. 

(a) (Tick-borne). There are no restrictions on case or contacts. 

(b) (Louse-borne) Cases and Suspect Cases to Be Reported by Tele- 
phone or Telegraph. (See Section 2501(c).) The patient shall be confined 
during the clinical phase of the disease in a dwelling or room free of ro- 
dents or lice. There are no restrictions on contacts. All lice and louse eggs 
on the patient's body, hair, or clothing shall be destroyed. Household 
contacts shall be louse-free. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

§2610. Rheumatic Fever, Acute. 

There are no restrictions on case or contacts. 
History 
1. Amendment filed 5-24-55; effecdve thirtieth day thereafter (Register 55, No. 
8). 

§ 261 1 . Rocky IVIountain Spotted Fever. 

There are no restrictions on case or contacts. 
History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

§ 2612. Salmonella Infections (Other Than Typhoid Fever). 

(a) Any illness in which organisms of the genus Salmonella (except the 
typhoid bacillus) have been isolated from feces, blood, urine or patholog- 
ical material shall be reported as a Salmonella infection. A culture of the 
organisms on which the diagnosis is established shall be submitted first 
to a local public health laboratory and then to the State Microbial Dis- 
eases Laboratory for definitive identification. The period of isolation in 
accordance with Section 25 1 8 shall be until clinical recovery. The patient 
shall be subject to supervision by the local health officer who may re- 
quire, at his discretion, release specimens of feces for testing in a labora- 
tory approved by the State Department of Health Services. 

However, no patient shall be released from supervision to engage in 
any occupation involving the preparation, serving or handUng of food, 
including milk, to be consumed by individuals other than his immediate 
family, nor to engage in any occupation involving the direct care of chil- 
dren or of the elderly or of patients in hospitals or other institutional set- 
tings until two successive authentic specimens of feces taken at intervals 
of not less than 24 hours, beginning at least 48 hours after cessation of 
specific therapy, if any was administered, have been determined, by a 
public health laboratory approved by the State Department of Health Ser- 
vices to be negative for Salmonella organisms. (See Section 2534.) 

(b) Carriers. Any person who harbors Salmonella organisms three 
months after onset is defined as a convalescent carrier and may be re- 
stricted at the discretion of the local health officer. 



Any person continuing to harbor Salmonella organisms one year after 
onset is a chronic carrier. Any person who gives no history of having had 
Salmonellosis or who had the illness more than one year previously who 
is found to harbor Salmonella organisms on two successive specimens 
taken not less than 48 hours apart is also considered to be a chronic carri- 
er. 

Chronic carriers of Salmonella, other than S. typhosa, shall be re- 
stricted at the discretion of the local health officer. 

(c) Contacts. Restrictions on contacts shall be at the discretion of the 
local health officer. 

NOTE: Authority cited: Sections 208 and 3123, Health and Safety Code. Refer- 
ence: Section 3123. Health and Safety Code. 

History 

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

2. Amendment filed 10-1 8-61 ; effective thirtieth day thereafter (Register 61 , No. 
21). 

3. Amendment filed 1 1-25-83; effective thirtieth day thereafter (Register 83, No. 
48). 



§ 261 2.1 . Turtle Salmonellosis. 

(a) Except as otherwise provided in this section, it shall be unlawful 
to import, sell or offer for sale or distribution to the public any live 
turtle(s) with a carapace length of less than 4 inches. 

(b) The Department or any authorized representative thereof, or any 
local health officer or his representative may order the humane destruc- 
tion of any turtle(s) that are unlawful to import, sell or offer for sale or 
distribution to the public under subsection (a) above. 

(c) The Department or any authorized representative thereof, or any 
local health officer or his representative may quarantine turtles, take sam- 
ples of tank water or any other appropriate samples of or from turtles of- 
fered for sale or distribution for the purpose of testing for Salmonella and 
Arizona organisms. The Department or any local health officer may order 
the immediate humane destruction of any lot of turtles found contami- 
nated with Salmonella, Arizona, or other organisms which may cause or 
have caused disease in humans. 

(d) Shipments of turtles under 4 inches in carapace length are per- 
mitted to a governmental agency, or to a recognized research or educa- 
tional institution for research or teaching purposes or to a zoological gar- 
den for display. 

(e) The following warning shall be posted conspicuously for buyer in- 
formadon at every display of turtles for retail sale or distribution or where 
the public may come in contact with turtles: 

CAUTION: Turtles may transmit bacteria causing disease in humans. It is im- 
portant to wash the hands thoroughly after handling turtles or material that had 
contact with turtles. Do not allow water or any other substance that had contact 
with turtles to come in contact with food or areas where food is prepared. Make 
sure that these precautions are followed by children and others handling turtles. 

(f) For each sale of turtle(s) at retail, a sales slip shall be issued by the 
seller to the purchaser at time of the sale. The sales slip shall include the 
name, address and telephone number of the purchaser and the seller, and 
the date of sale. The sales slip shall have printed legibly on its front the 
warning statement contained in subsection (e) above. The seller shall 
keep a copy of the sales slip, which shall include the name, address and 
telephone number of the purchaser for not less than one year, and keep 
a complete record of all purchases, losses and other dispositions of 
turtles. 

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: 
Sections 205, 3051-3053, Health and Safety Code. 

History 

1. New section filed 10-5-72; effective thirtieth day thereafter (Register 72, No. 
41). 

2. Amendment filed 10-7-77; effective thirtieth day thereafter (Register 77, No. 
41). 

§ 2613. Shigella Infections (Dysentery, Bacillary). 

(a) The period of isolation in accordance with Section 2518 shall be 
until the acute symptoms have subsided. 



Page 74 



Register 2002, No. 29; 7-19-2002 



Title 17 



State Department of Health Services 



§2626 



The palicnt shall be subject to supervision by the local health officer 
who may require, at his discretion, release specimens of feces for testing 
in a laboratory approved by the State Department of Health Services. 
However, no patient shall be released from supervision to engage in any 
occupation involving the preparation, serving or handling of food, in- 
cluding milk, to be consumed by individuals other than his immediate 
family, nor to engage in any occupation involving the direct care of chil- 
dren or of the elderly or of patients in hospitals or other institutional set- 
tings until two successive authentic specimens of feces or of rectal swabs, 
taken at intervals of not less than 24 hours, beginning at least 48 hours 
after cessation of specific therapy, if any was administered, have been de- 
termined, by a public health laboratory approved by the State Department 
of Health Services, to be negative for Shigella organisms. (See Section 
2534.) 

(b) Contacts. Restrictions on contacts shall be at the discretion of the 
local health officer. 

NOTE; Authority cited: Sections 208 and 3123, Health and Safety Code. Refer- 
ence: Section 3123, Health and Safety Code. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 



2. Amendment filed 10-18-61; effective thirtieth day thereafter (Register 61, No. 
21). 

3. Amendment filed 1 1-25-83; effective thirtieth day thereafter (Register 83, No. 
48). 



§ 2614. Smallpox (Variola). Cases and Suspect Cases to 
Be Reported by Telephone. 

(See Section 2502(c).) 

(a) Patient. The patient shall be isolated in accordance with Section 
25 1 6 until the scabs have separated and the scars have completely healed. 

(b) Household Contacts. Household contacts shall be quarantined for 
at least 17 days after last exposure, except that the local health officer 
may, at his discretion, when the patient is properly isolated, release from 
quarantine persons who shall submit to vaccination against smallpox and 
prove to the satisfaction of the local health officer that the vaccination is 
successful. Such persons shall remain in quarantine until released by the 
local health officer. 

(c) Casual Contacts. A person who has been exposed to the risk of con- 
tracting the disease by proximity to a case or to a suspected case of small- 
pox, shall be quarantined for a period not less than 17 days from the last 
date of exposure. Such persons may be released from quarantine if evi- 
dence of protection against smallpox is established to the satisfaction of 
the local health officer. 

(d) Vaccination. The local health officer shall provide at public ex- 
pense, as available, smallpox vaccination for persons who have been ex- 
posed to a case or suspected case of smallpox. 

(e) Laboratory. Whenever a laboratory receives a specimen for the lab- 
oratory diagnosis of smallpox (variola), such laboratory shall communi- 
cate immediately by telephone with the State Department of Health Ser- 
vices Viral Rickettsial Disease Laboratory for instruction. 

NOTE: Authority cited : Sections 1 00 1 80, 1 00275, 1 20 1 30 and 1 201 45, Health and 
Safety Code. Reference: Sections 100180, 100275, 120130, 120190, 120195 and 
120215, Health and Safety Code. 

History 

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

2. Amendment of section heading and section and new Note filed 1 1-5-2001 as 
an emergency; operative 1 1-3-2001 (Register 2001, No. 45). A Certificate of 
Compliance must be transmitted to OAL by 3-5-2002 or emergency language 
will be repealed by operation of law on the following day. 

3. Amendment of section heading and section and new Note refiled 3-1-2002 as 
an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of 
CompHance must be transmitted to OAL by 7-1-2002 or emergency language 
will be repealed by operation of law on the following day. 

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 
and filed 7-16-2002 (Register 2002, No. 29). 



§ 2616. Streptococcal Infections, Hemolytic (Including 

Scarlet Fever and Streptococcal Sore Throat). 

(a) The patient shall be isolated in accordance with Section 2518 for 
not less than seven days from onset. Patients treated with an effective an- 
tibiotic may be released upon clinical recovery. 

(b) Contacts. Household contacts should be kept under frequent medi- 
cal observation for the development of streptococcal disease. Restriction 
on contacts is not required, except at the discretion of the local health offi- 
cer. 

History 

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 

8). 

§2617. Syphilis. 

(See Section 2636 on Venereal Diseases.) 

§2618. Tetanus. 

There are no restrictions on case or contacts. 
History 

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

§ 2620. Trachoma. 

The patient shall be isolated in accordance with Section 2518 during 
the acute stages and when not under medical treatment satisfactory to the 
health officer. There are no restrictions on contacts. 

§ 2622. Trichinosis. 

The local health officer shall make an investigation to determine the 
source of infection. If the suspected source is a commercial food product, 
the health officer shall report the fact at once to the State Department of 
Public Health. There are no restrictions on case or contacts. 

§ 2624. Tuberculosis. 

A person having or suspected of having tuberculosis in a communica- 
ble stage shall be considered as fulfilling the requirements of modified 
isolation as long as he is under adequate medical supervision and ob- 
serves the instructions issued by the local health officer. The isolation 
shall be adequate for the protection of persons residing within the house- 
hold as well as the public. 

A person having tuberculosis in a communicable stage, who refuses 
to observe the instructions of the local health officer and thereby need- 
lessly exposes others to infection, shall be placed in strict isolation at 
home until such time as the local health officer feels that such isolafion 
is no longer necessary for the protection of the public; and, in the event 
that such household isolafion proves inadequate for the protection of 
members of the household or community, the pafient shall be placed in 
isolafion in quarters designated by the local health officer, until such time 
as such isolafion is no longer necessary for the protecfion of the public. 

The person officially in charge of a sanatorium or other place where 
tuberculosis patients are cared for shall be responsible for immediately 
nofifying the health officer in whose territory a patient resides whenever 
such pafient having tuberculosis in a communicable stage leaves the in- 
stitution. 

In every case in which a non-communicable tuberculous pafient has 
been placed in a nursing home the local health officer or his deputy shall 
be responsible for the confinued surveillance of such a pafient to ensure 
that he remains non-communicable. 

History 
1 . Amendment filed 12-22-69; effective thirtieth day thereafter (Register 69, No. 

52). 

§ 2626. Tularemia. Cases and Suspect Cases to Be 
Reported by Telephone. 

(See Section 2502(c).) 

There are no restricfions on case or contacts. Whenever a laboratory 
receives a specimen for the laboratory diagnosis of suspected human tu- 
laremia, such laboratory shall communicate immediately by telephone 
with the State Department of Health Services Microbial Diseases Labo- 
ratory for instruction. 



Page 75 



Register 2002, No. 29; 7-19-2002 



§2628 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



Note: Authority cited: Sections 100180, 100275 and 120130, Health and Safety 
Code. Reference: Sections 100180, 100275, 120130 and 120190, Health and Safe- 
ty Code. 

History 

1 . Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 
8). 

2. Amendment of section heading and section and new NoTK filed 1 1-5-2001 as 
an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A Certificate of 
Compliance must be transmitted to OAL by 3-5-2002 or emergency language 
will be repealed by operation of law on the following day. 

3. Amendment of section heading and section and new Nori. refiled 3-1-2002 as 
an emergency; operative 3-1-2002 (Register 2002. No. 9). A Certificate of 
Compliance must be transmitted to OAL by 7-1-2002 or emergency language 
will be repealed by operation of law on the following day. 

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 
and filed 7-16-2002 (Register 2002, No. 29). 

§ 2628. Typhoid Fever. 

(a) Case. A culture of the organism on which the diagnosis of typlioid 
fever is established shall be submitted first to a local public health labora- 
tory and then to the State Microbial Diseases Laboratory for phage typ- 
ing. The patient shall be isolated in accordance with Section 2518 until 
clinical recovery. The patient shall remain subject to supervision by the 
local health officer until three successive specimens of feces and urine 
taken at least 24 hours apart, beginning at least one week after disconti- 
nuation of specific therapy and not earlier than one month after onset of 
disease, have been found negafive for typhoid bacilli at a public health 
laboratory approved by the State Department of Health Services. If any 
one of this series is positive, cultures of both urine and feces shall be re- 
peated at intervals of 1 month during the 12-month period following on- 
set, until at least three sets of negative cultures are obtained. The padent 
shall not take any part in the preparation, serving, or handling of milk or 
other food to be consumed by individuals other than his immediate fami- 
ly, or parficipate in the management of a dairy, milk distribuUng plant, 
boarding house, restaurant, food store, or any place where food is pre- 
pared or stored, or engage in any occupation involving the direct care of 
young children or the elderly or of pafients in hospitals or other institu- 
tional settings until release specimens have been obtained, as described 
above, and are negative for typhoid organisms. (See Section 2534.) 

(b) Contacts. There are no restrictions on contacts, except that any 
member of the patient's household shall not take part in the preparauon, 
serving, or handling of milk or other food to be consumed by individuals, 
other than the immediate family except at the discretion and under the re- 
strictions of the local health officer. 

(c) Definition of Carriers. ( 1 ) Convalescent Carriers: Any person who 
harbors typhoid bacilli for three or more months after onset is defined as 
a convalescent carrier. Convalescent carriers may be released when three 
consecutive negative specimens of feces and urine taken at intervals of 
not less than one month, beginning at least one week after discontinua- 
tion of specific therapy are obtained. Such release may be granted at any 
time from 3-12 months after onset. 

(2) Chronic Carriers: If the person continues to excrete typhoid bacilli 
for more than 12 months after onset of typhoid fever, he is defined as a 
chronic carrier. Any person who gives no history of having had typhoid 
fever or who had the disease more than one year previously, and whose 
feces or urine are found to contain typhoid bacilli on two separate exami- 
nations at least 48 hours apart, confirmed by State Microbial Diseases 
Laboratory, is also defined as a chronic carrier. All carriers shall be re- 
ported to the local health officer. Such reports shall be kept confidential 
and shall not be divulged to persons other than the carrier and his immedi- 
ate family, except as may be required for the protection of the public 
health. 

(3) Other Carriers: A person should be held under surveillance if ty- 
phoid bacilli are isolated from surgically removed tissues, organs, e.g., 
gallbladder, kidney, etc., or from draining lesions such as osteomyelitis. 
If the person continues to excrete typhoid bacilli for more than 12 months 
he is defined as a chronic carrier and may be released after safisfying the 
criteria for other chronic carriers. 



(d) Carrier Restricfions and Supervision. When any known or sus- 
pected carrier of this disease is reported to the local health officer, he shall 
make an investigation and submit a report to the State Department of 
Health Services. He shall have performed laboratory work as defined in 
subsecUon (e) below. Any known or suspected carrier of this disea.se 
shall be subject to modified isolation and the provisions of this isolaUon 
shall be considered as fulfilled during such period as he complies with 
the instnictions issued by the State Department of Health Services and 
the local health officer. 

(1 ) Restrictions. Instructions shall be given to the carrier in writing by 
the local health officer. 

(2) Supervision. The local health officer or his representadve shall 
communicate with each carrier living within his jurisdiction at least twice 
a year to learn of any changes in the carrier's address, occupation or acti- 
vifies and to determine whether all instructions are being carried out. The 
local health officer shall submit a report to the State Department of Health 
Services every six months on each carrier in his jurisdicUon. Any 
changes of address shall be reported immediately. 

(e) Laboratory Tests. Whenever laboratory tests are required for the 
release of typhoid cases or carriers, the tests shall be taken by the local 
health officer or his representatives under such conditions that he can cer- 
tify as to their being authentic specimens of the individual, and shall be 
submitted to a public health laboratory approved by the State Department 
of Health Services. Cultures from release speciinens which are found 
posifive by the approved laboratory shall be forwarded to the State Divi- 
sion of Laboratories for phage typing. 

(f) Requirements for Release of Chronic Carriers. Authority for Re- 
lease of Carriers. Any person ascertained to be a chronic typhoid carrier 
may be released from supervision by the Director of the State Department 
of Health Services or his designated representative provided the carrier 
applies for such release through his local health officer and fulfills the re- 
quirements specified by the Director of the State Health Department or 
his designated representadve. 

(1 ) Fecal Carriers. A person who has been determined to be a chronic 
fecal carrier may be released if six successive authendc stool and urine 
specimens taken at intervals of not less than one month are determined 
to be negative by a public health laboratory approved by the State Depart- 
ment of Health Services. If any one of these specimens is posidve. he 
shall not be released unless the carrier condition has been cured by chole- 
cystectomy, or by such other methods as are acceptable to the State De- 
partment of Health Services. The necessary requirements for such re- 
lease will be submitted to the carrier and to the local health officer by the 
State Department of Health Services when application for the release is 
submitted. 

(2) Cholecystectomy. The local health officer or, in areas not served 
by a local health department, the Director of the State Department of 
Health Services, shall be notified before a cholecystectomy is undertaken 
unless a specimen of duodenal contents, containing bile, has been found 
positive for typhoid bacilli, since in some cases the infection is not local- 
ized in the gall bladder. The patient shall be released under the same con- 
ditions as outiined for a fecal carrier. 

(3) Urinary Carriers. A person who has been determined to be a chron- 
ic urinary carrier may be released if six successive authentic urine speci- 
mens taken at intervals of not less than one month are determined to be 
negative by a public health laboratory approved by the State Department 
of Health Services. If any one of these specimens is positive, he may be 
released following the surgical removal of the infected kidney or by such 
other methods as are acceptable to the State Department of Health Ser- 
vices. The necessary requirements for such release will be submitted to 
the carrier and to the local health officer by the State Department of 
Health Services when apphcation for the release is submitted. 

NOTE: Authority cited: Sections 208 and 3123, Health and Safety Code. Refer- 
ence: Section 3123, Health and Safety Code. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 



Page 76 



Register 2002, No. 29; 7-19-2002 



Title 17 



State Department of Health Services 



§2636 



2. Amendment filed 10-18-61; effective thirtieth day thereafter (Register 61, No. 
21). 

3. Amendment filed 1 1-25-83; effective thirtieth day thereafter (Register 83, No. 

48). 

§ 2630. Typhus Fever (Flea-Borne, Endemic Type). 

The patient shall be confined during the clinical phase of the disease 
in a dwelling or room free of rodents, fleas or lice. There are no restric- 
tions on contacts. 

History 
1. Amendment filed 5-24-53; effective thirtieth day thereafter (Register 55, No. 

8). 

§ 2632. Typhus Fever (Louse-Borne, Epidemic Type). 

Cases and Suspect Cases to Be Reported by 
Telephone or Telegraph. 

(See Section 250 1 (c). ) The patient shall be confined during the clinical 
phase of the disease in a dwelling or room free of rodents or lice. All lice 
and louse eggs on the patient's body, hair, or clothing shall be destroyed. 
Household contacts shall be louse-free. There are no other restrictions 
on contacts. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 

8.) 

§ 2636. Venereal Diseases. 

(a) Sections 2636 to 2636(m) inclusive pertain to the venereal diseases 
and, unless otherwise specified, shall include syphilis, gonococcus infec- 
tion, granuloma inguinale, lymphogranuloma venereum, and chancroid. 
(See Chapter 765, Statutes 1947; also Section 21 100, Health and Safety 
Code.) 

(b) Reports Confidential. Reports of examinations, cases, investiga- 
tions and all records thereof made under the regulations for the control 
of venereal diseases shall be confidential and not open to public inspec- 
tion and no part thereof divulged, except as may be necessary for the pres- 
ervation of the public health. 

(c) Report of Unusual Prevalence. When the local health officer, 
through investigation, becomes aware of unusual prevalence of venereal 
diseases, or of unusual local conditions favoring the spread of these dis- 
eases, he shall report the fact at once to the State Department of Health 
Services. 

(d) Parents or Guardians Responsible for Compliance of Minors. The 
parents or guardians of minors suffering from a venereal disease shall be 
legally responsible for the compliance of such minors with the require- 
ments of the regulations relating to the venereal diseases. 

(e) Certification. Each local health officer shall take every proper 
means of repressing prostitution, inasmuch as it is the most prolific 
source of the venereal diseases. Health officers and physicians shall not 
issue certificates of freedom from venereal diseases to known prostitutes, 
as such certificates may be used for purposes of solicitation. 

(0 Diagnosis. The local health officer may require the submission of 
such specimens as may be designated from cases of venereal disease for 
examination in a laboratory approved by the State Department of Health 
Services. The local health officer may require any physician in atten- 
dance on a person infected with a venereal disease or suspected of being 
infected with a venereal disease to submit such specimens as approved 
by the State Department of Health Services provided, however, nothing 
shall prevent the physician or individual from having additional exami- 
nation made elsewhere. 

(g) Instruction to the Patient. It shall be the duty of the physician in at- 
tendance on a person having a venereal disease, or suspected of having 
a venereal disease, to instruct such patient in precautionary measures for 
preventing the spread of the disease, the seriousness of the disease, and 
the necessity for treatment and prolonged medical supervision, and the 
physician shall, in addition, furnish approved literature on these subjects. 
Approved literature for distribution to patients may be secured from the 
State Department of Public Health and the local health departments free 
of charge. 



(h) Investigation. All city, county and other local health officers are 
hereby directed to use every available means to ascertain the existence 
of, and immediately to investigate, all reported or suspected cases of ve- 
nereal disease in the infectious stages within their several territorial juris- 
dictions, and to ascertain the sources of such infections. The attending 
physician, in every case of venereal disease coming to him for treatment, 
shall endeavor to discover the source of infection, as well as any sexual 
or other intimate contacts which the patient was in the communicable 
stage of the disease. The physician shall make an effort, through the 
cooperation of the patient, to bring these cases in for examination and, 
if necessary , treatment. If, within 10 days of identification, any such 
source of infection or any such contact has not given satisfactory evi- 
dence of being under the care of a physician, such person shall be re- 
ported to the health officer, the physician's name being kept confidential 
in any investigation by the health department. In cases in which prosti- 
tutes are named as sources of infection, all obtainable information as to 
name, description, residence, etc., shall be given to the health officer at 
once. 

In carrying out such investigations, all health officers are hereby in- 
vested with full powers of inspection, examination and isolation of all 
persons known to be infected with a venereal disease in an infectious 
stage, or suspected of being infected with a venereal disease in an infec- 
tious stage and are hereby directed: 

(1) To make such examinations as are deemed necessary of persons 
reasonably suspected of having a venereal disease in an infectious stage. 

(2) When the individual to be examined is a woman, to provide the ser- 
vices of a woman physician if such physician is available, when so re- 
quested by the individual to be examined. 

(3) To isolate such person, whenever deemed necessary for the protec- 
tion of the public health. In establishing isolation the health officer shall 
proceed as provided in Sections 2636(i), 2636(j), 2636(1) and 2636(m). 

(4) Pursuant to Secfion 3 194.5 of the Health and Safety Code, a person 
employed by a Public Health Department shall meet the following train- 
ing requirements as a prerequisite to the performance of venipuncture or 
skin puncture: 

(A) Possess a statement signed by a licensed physician and surgeon 
stating that the individual named in such statement has received adequate 
training in the proper procedure to be employed in the performance of ve- 
nipuncture and skin puncture. 

(B) In order to receive such statement, the venereal disease case inves- 
tigator shall be trained by a licensed physician and surgeon. The trainee 
shall observe and receive sufficient instruction and demonstration of the 
proper technique and procedure to be employed in the performance of ve- 
nipunctures and skin punctures; in turn, the physician and surgeon shall 
then observe the procedure and technique of the trainee. 

(C) When such training has been completed by the trainee to the satis- 
facfion of the physician and surgeon, such physician and surgeon shall 
execute a statement that the venereal disease case investigator has re- 
ceived adequate training in the proper procedure to be employed in the 
performance of venipuncture and skin puncture. 

Satisfacfion of these training requirements shall be in addifion to other 
requirements of Section 3194.5 of the Health and Safety Code. 

(i) Isolation. Any person who presents himself (or herself) to any phy- 
sician or person for treatment or diagnosis of any venereal disease except 
late syphilis shall be considered to be in modified isolation. The require- 
ments of this isolation shall be considered fulfilled if the patient remains 
under adequate and proper treatment until the completion of the course 
of treatment, except in instances in which, because of occupation, suspi- 
cion of prostitution, or other reason, the health officer deems more strict 
isolation necessary to safeguard other persons. 

(j) Violation of Isolation to be Reported. Whenever any person while 
in the infectious or potentially infectious stage of a venereal disease, 
lapses from treatment for a period of more than 1 days after the time ap- 
pointed for such treatment, the said diseased person shall be deemed to 
have violated the requirements of isolation, and the physician or person 
in attendance upon such case shall report the same at once to the local 



Page 76.1 



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§2638 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



health department, giving the person's name, address, and report num- 
ber, together with such other information as requested on the card pro- 
vided for this purpose, except that this sliall not be required in instances 
in which a report has been received that the patient is under treatment 
elsewhere. 

(k) If any person has knowledge that a person infected with a venereal 
disease is failing to observe adequate precautions to prevent spreading 
infection, he shall report the facts at once to the local health officer. 

(/) Gonorrhea. A case of gonococcus infection of the genitourinary 
tract shall be regarded as subject to isolation until the local health officer 
is reasonable satisfied that the disease is no longer communicable. 

(m) Syphilis. A case of syphilis shall be regarded as subject to isolation 
until, under treatment, all syphilitic lesions of the skin or mucous mem- 
brane are completely healed and a competent clinical examination fails 
to show the presence of any area from which infection may be spread. 
Any patient who refuses or otherwise fails to receive a full course of a 
currently accepted method of treatment, or who discontinues treatment 
prematurely, may be subjected to strict isolation if the health officer 
deems it necessary. 

NOTE: Authority cited: Sections 102.208 and 3194.5, Health and Safety Code. 
Reference: SecUon 3194.5, Health and Safety Code. 

History 

1 . New subsecdon (h)(4) filed 2-14-73; effective thirtieth day thereafter (Register 
73, NO. 7). 



§ 2638. Viral Hemorrhagic Fevers (e.g., Crimean-Congo, 
Ebola, Lassa and Marburg Viruses). Cases and 
Suspect Cases to Be Reported by Telephone. 

(See Section 2502(c).) 

(a) Patient. The patient shall be isolated in accordance with Section 
25 1 6. Strict barrier isolation and patient blood, secretion and excreta pre- 
cautions shall be enforced. The patient shall be instructed to refrain from 
unprotected sexual activity until secretions are free of virus or for 3 
months after illness onset. 

(b) Laboratory. Whenever a laboratory receives a specimen for labora- 
tory diagnosis of suspected viral hemorrhagic fevers, such laboratory 
shall communicate immediately by telephone with the State Department 
of Health Services Viral and Rickettsial Disease Laboratory for instruc- 
tions. 

NOTE: Authority cited: Sections 100180, 100275, 120130, 120145 and 120175, 
Health and Safety Code. Reference: Sections 100180, 100275, 120130, 120185, 
120190, 120195, 120215 and 120240, Health and Safety Code. 

History 

1 . New section filed 1 1-5-2001 as an emergency; operative 1 1-5-2001 (Register 

2001, No. 45). A Certificate of Compliance must be transmitted to OAL by 
3-5-2002 or emergency language will be repealed by operation of law on the 
following day. 

2. New section refiled 3-1-2002 as an emergency; operative 3-1-2002 (Register 

2002, No. 9). A Certificate of Compliance must be transmitted to OAL by 
7-1-2002 or emergency language will be repealed by operation of law on the 
following day. 

3. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002 
and filed 7-16-2002 (Register 2002, No. 29). 



§ 2640. Yellow Fever Cases and Suspect Cases to Be 
Reported by Telephone or Telegraph. 

(See Section 2501(c).) The case shall be confined during the clinical 
phase of the disease in a room satisfactorily protected against mosqui- 
toes. Contacts shall be kept under observation for a period of seven days 
after the date of last exposure. 

History 
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 

8). 



Article 3.5. Reporting of Human 
Immunodeficiency Virus (HIV) Infection 



Subarticlel. Definitions 

§ 2641 .5. Alternative Testing Site. 

"Alternative Testing Site" means an anonymous HIV testing site 
funded by the California Department of Public Health, administered by 
a county health department and operated pursuant to Health and Safety 
Code, Sections 120890-120895. 

Note. Authority cited: Sections 1 20 1 25, 1 201 30, 1 3 1 080 and 1 3 1 200, Health and 
Safety Code. Reference: Sections 120175, 120775. 120885-120895, 121025, 
131051, 131052, 131056 and 131080, Health and Safety Code. 

History 
l.Newarticle3.5(subarticles 1 and 4), subarticle 1 (sections 2641. 5-2641. 90) and 

section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 
2. Amendment of section and Notf. filed 2-6-2008; operative 2-6-2008 (Register 

2008, No. 6). 

§ 2641 .1 0. Anonymous Counseling and Testing Program. 

"Anonymous Counseling and Testing Program" means a program of- 
fering HIV counseling and testing while maintaining anonymity of the 
patient. 

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and 
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 
121025, Health and Safety Code. 

History 
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

§ 2641 .1 5. Anonymous HIV Test. 

"Anonymous HIV Test" means an HIV test that maintains the ano- 
nymity of the patient. 

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and 
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 
121025, Health and Safety Code. 

History 
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

§ 2641 .20. Biological Specimen. 

"Biological specimen" means any material that is derived from the hu- 
man body. 

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and 
Safety Code. Reference: Section 1206, Business and Professions Code; and Sec- 
tions 100180, 101160, 120175, 120775, 120885-120895 and 121025, Health and 
Safety Code. 

History 
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

§ 2641 .25. Confidential HIV Test. 

"Confidential HIV Test" means an HIV test that links the test results 
to the patient in a restricted manner to protect against unauthorized dis- 
closure of the identity of the patient. 

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and 
Safety Code. Reference: Sections 100180, 120175, 120775 and 121025, Health 
and Safety Code. 

History 
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

§ 2641 .30. Confirmed HIV Test. 

"Confirmed HIV test" means: 

(a) a procedure which verifies the presence of HIV infection as deter- 
mined by any clinical laboratory test or HIV Test Algorithm or examina- 
tion used to detect the presence of HIV, a component of HIV, or antibo- 
dies to or antigens of HIV, including the HIV antibody (HIV-Ab), HIV 
p-24 antigen, Western blot (Wb), and immunofluorescence antibody 
tests; or 

(b) for the purpose of this Article, all tests used to monitor HIV infec- 
tion, including HIV nucleic acid detection. 



Page 76.2 



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Title 17 



State Department of Health Services 



§ 2641.57 



NOTE: Authority cited: Sections 120125, 120130, 121022, 131080 and 131200, 
Health and Safety Code. Reference: Sections 1206, 1206.5, 1241, 1265 and 1281, 
Business and Professions Code; and Sections 101 150, 101 160, 120175, 120775, 
120885-120895, 121025, 120917, 121022, 131051. 131052, 131056 and 131080, 
Health and Safety Code. 

History 

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

2. Amendment of subsection (a) and NOTH filed 1-8-2007 as an emergency pur- 
suant to Health and Safety Code section 121022, subdivision (c); operative 
1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be trans- 
mitted to OAL by 5-8-2007 or emergency language will be repealed by opera- 
tion of law on the following day. 

3. Amendment of subsection (a) and NOTi-; refiled 4-18-2007 as an emergency 
pursuant to Health and Safety Code section 121022, subdivision (c); operative 
5-9-2007 (Register 2007. No. 16). A Certificate of Compliance must be trans- 
mitted to OAL by 9-6-2007 or emergency language will be repealed by opera- 
tion of law on the following day. 

4. Amendment ofsubsection (a) and NoTH refiled with further amendment of Note 
8-21-2007 as an emergency pursuant to Health and Safety Code section 
12] 022. subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certifi- 
cate of Compliance must be transmitted to OAL by 1-7-2008 or emergency lan- 
guage will be repealed by operation of law on the following day. 

5. Certificate of Compliance as to 8-21-2007 order, including further amendment 
of subsection (a), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Regis- 
ter 2008. No. 6). 

§ 2641 .35. Department. 

"Department" means the California Department of Public Health, Of- 
fice of AIDS. 

NOTti: Authority cited: Sections 120125, 120130. 131080 and 13 1200, Health and 
Safetv Code. Reference: Sections 120175, 120775, 120885-120895, 121025, 
131051, 131052, 131056 and 131080, Health and Safety Code. 

History 

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

2. Amendment of section and Note filed 2-6-2008; operative 2-6-2008 (Register 
2008, No. 6). 

§ 2641 .45. Health Care Provider. 

"Health care provider" means an individual who obtains the results of 
an HIV test or HIV test algorithm or submits a biological specimen to a 
laboratory for a test to detect the presence of HIV, a component of HIV 
or antibodies to or antigens of HIV, receives the test results and is; 

(a) licensed under the provisions of Business and Professions Code, 
Division 2 (Healing Arts) and acting within his or her scope of practice, 
or; 

(b) a designee of a physician and surgeon acting under the general su- 
pervision of that physician or surgeon, or; 

(c) a person working in a pubHcly-funded confidential counseling and 
testing program acting under the general supervision of, and following 
the protocols approved by, the local Health Officer for the local health 
department. 

NOTE: Authority cited: Sections 101160, 120125, 120130, 121022, 131080 and 
131200, Health and Safety Code. Reference: Sections 1206, 1206.5, 1241, 1281 
and 1285, Business and Professions Code; and Sections 120175, 120775, 
120885-120895, 120917, 121022, 121025, 131051, 131052, 131056 and 131080, 
Health and Safety Code. 

History 

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

2. Amendment of first paragraph and Note filed 1-8-2007 as an emergency pur- 
suant to Health and Safety Code section 121022, subdivision (c); operative 
1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be trans- 
mitted to OAL by 5-8-2007 or emergency language will be repealed by opera- 
tion of law on the following day. 

3. Amendment of first paragraph and Note refiled 4-18-2007 as an emergency 
pursuant to Health and Safety Code secfion 121022, subdivision (c); operative 
5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be trans- 
mitted to OAL by 9-6-2007 or emergency language will be repealed by opera- 
tion of law on the following day. 

4. Amendment of first paragraph and Note refiled with further amendment of 
Note 8-21-2007 as an emergency pursuant to Health and Safety Code section 
121022, subdivision (c); operafive 9-7-2007 (Register 2007, No. 35). A Certifi- 
cate of Compliance must be transmitted to OAL by 1-7-2008 or emergency lan- 
guage will be repealed by operation of law on the following day. 

5. Certificate of Compliance as to 8-2 1-2007 order, including further amendment 
of first paragraph, transmitted to OAL 12-21-2007 and filed 2-6-2008 (Resis- 
ter 2008, No. 6). 



§ 2641 .50. Health Officer and Local Health Officer. 

"Health Officer and Local Health Officer" means the officer ap- 
pointed by the local governing body (county, city, and district), as de- 
fined in Section 2500. 

NOTE: Authority cited: Sections 1 00 1 80, 1 00275, 1 20 1 25 and 1 20 1 30, Health and 
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 
121025. Health and Safety Code. 

History 

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002. No. 18). 

§ 2641 .55. HIV/AIDS Case Report. 

"HIV/AIDS Case Report" means California Departinent of Public 
Health HIV/AIDS Confidential Case Report form. Adult (CDPH 8641 A 
(05/07)) or Pediatric (CDPH 864 IP (05/07)), hereby incorporated by ref- 
erence in this Article and available from the local health department or 
the Department. 

NOTE: Authority cited: Sections 120125, 120130, 121022, 131080 and 131200, 
Health and Safety Code. Reference: Secfions 120175, 120775, 120885-120895, 
121022, 121025, 121035, 131019, 131051, 131052, 131056 and 131080, Health 
and Safety Code. 

History 

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

2. Amendment of section and Note filed 1-8-2007 as an emergency pursuant to 
Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 
(Register 2007. No. 2). A Certificate of Compliance must be transmitted to OAL 
by 5-8-2007 or emergency language will be repealed by operation of law on 
the following day. 

3. Amendment of section and Note refiled with further amendments 4-18-2007 
as an emergency pursuant to Health and Safety Code section 121022. subdivi- 
sion (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Com- 
pliance must be transmitted to OAL by 9-6-2007 or emergency language will 
be repealed by operation of law on the following day. 

4. Amendment of section and Note refiled with further amendment of Note 
4-18-2007 as an emergency pursuant to Health and Safety Code section 
121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). ACertifi- 
cate of Compliance must be transmitted to OAL by 1-7-2008 or emergency lan- 
guage will be repealed by operation of law on the following day. 

5. Certificate of Compliance as to 8-21-2007 order, including further amendment 
of section, transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, 
No. 6). 

§ 2641 .56. HIV/AIDS Confidentiality Agreement. 

"HIV/AIDS Confidentiahty Agreement" means California Depart- 
ment of Public Health HIV/AIDS Confidentiahty Agreement form 
(CDPH 8689 (05/07)), hereby incorporated by reference and available 
from the Department. 

NOTE: Authority cited: Secfions 120125, 120130, 121022, 131080 and 131200, 
Health and Safety Code. Reference: Secfions 120175, 120775, 120820, 
120885-120895, 120975, 120980, 121022. 121025. 121035, 121110, 131019, 
131051, 131052, 131056 and 131080, Health and Safety Code. 

History 

1 . New secdon filed 1 -8-2007 as an emergency pursuant to Health and Safety 
Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 
2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or 
emergency language will be repealed by operation of law on the following day. 

2. New section refiled 4-1 8-2007 as an emergency pursuant to Health and Safety 
Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007. No. 
16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or 
emergency language will be repealed by operation of law on the following day. 

3. New section refiled with further amendment of NoTi-; 8-21-2007 as an emer- 
gency pursuant to Health and Safety Code section 121022, subdivision (c): op- 
erative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be 
transmitted to OAL by 1-7-2008 or emergency language will be repealed by 
operation of law on the following day. 

4. Certificate of Compliance as to 8-21-2007 order, including further amendment 
of section and Note, transmitted to OAL 1 2-2 1 -2007 and filed 2-6-2008 ( Reg- 
ister 2008, No. 6). 

§ 2641 .57. HIV Test Algorithm. 

"HIV test algorithm" means any multi-test procedure that determines 
the presence of HIV infection using confirmation protocols published in 
the Centers for Disease Control and Prevenfion's Morbidity and Mortal- 
ity Weekly Report (MMWR). 

NOTE: Authority cited: Sections 120125, 120130. 121022. 131080 and 131200. 
Health and Safety Code. Reference: Secfions 1206 and 1220. Business and Profes- 
sions Code; and Sections 120917, 121022, 131051. 131052 and 131056. Health 
and Safety Code. 



Page 76.3 



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§ 2641.60 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



History 

1. New section filed 1-8-2007 as an emergency pursuant to Health and Safety 
Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 
2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or 
emergency language will be repealed by operation of law on the following day. 

2. New section refiled 4-18-2007 as an eimergency pursuant to Health and Safety 
Code section 121022. subdivision (c); operative 5-9-2007 (Register 2007, No. 
16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or 
emergency language will be repealed by operation of law on the following day. 

3. New section refiled with further amendment of Notf 8-21-2007 as an emer- 
gency pursuant to Health and Safety Code section 121022, subdivision (c): op- 
erative 9-7-2007 (Register 2007. No. 35). A Certificate of Compliance must be 
transmitted to OAL by 1-7-2008 or emergency language will be repealed by 
operation of law on the following day. 

4. Certificate of Compliance as to 8-2 1-2007 order, including further amendment 
of section, transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, 
No. 6). 

§ 2641 .60. Laboratory. 

"Laboratory" means a 'clinical laboratory,' a 'physician office labora- 
tory," or a 'public health laboratory,' as defined in Business and Profes- 
sions Code. Section 1206, that is authorized to perform clinical laborato- 
ry tests or examinations in California, or a clinical laboratory located 
outside of the State of California that is licensed pursuant to Business and 
Professions Code Section 1241(a) and that tests specimens originating in 
California. 

NOTE: Authority cited: Sections 1224 and 1288, Business and Professions Code; 
and Sections 100180, 100275, 101160, 120125 and 120130, Health and Safety 
Code. Reference: Sections 1206, 1220, 1241, 1265 and 1281, Business and Profes- 
sions Code. 

History 
1. New section filed 5-2-2002: operafive 7-1 -2002 (Register 2002, No. 18). 

§ 2641 .65. Laboratory Test. 

"Laboratory test" means a clinical laboratory test or examination as 
defined in Business and Professions Code, Section 1206(a)(4) and per- 
formed by a laboratory as defined in this Article. 

NOTE: Authority cited: Sections 1224 and 1288, Business and Professions Code; 
and Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Ref- 
erence: Sections 1202.5 and 1206. Business and Professions Code; and Section 
101 160, Health and Safety Code. 

History 
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

§ 2641.70. Local Health Department. 

"Local health department" means the governing body providing pub- 
lic health services to cities and/or counties, as identified in Health and 
Safety Code, Section 101 185. 

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and 
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 
121025, Health and Safety Code. 

History 

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

§ 2641 .75. Non-Name Code. [Repealed] 

NOTE: Authority cited: Sections 100180, 100275, 120125, 120130 and 120140, 
Health and Safety Code. Reference: Sections 100180, 120175, 120775, 
120885-120895 and 121025, Health and Safety Code. 

History 

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

2. Repealer filed 1-8-2007 as an emergency pursuant to Health and Safety Code 
section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A 
Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emer- 
gency language will be repealed by operation of law on the following day. 

3. Repealer refiled 4-18-2007 as an emergency pursuant to Health and Safety 
Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 
16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or 
emergency language will be repealed by operation of law on the following day. 

4. Repealer refiled 8-21-2007 as an emergency pursuant to Health and Safety 
Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 
35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or 
emergency language will be repealed by operation of law on the following day. 

5. Certificate of Compliance as to 8-21-2007 order transmitted to OAL 
12-21-2007 and filed 2-6-2008 (Register 2008, No. 6). 



§ 2641 .77. Partial Non-Name Code. [Repealed] 

NOTE: Authority cited: Sections 100180. 100275, 120125, 120130 and 120140 
Health and Safety Code. Reference: Sections 100180, 120175, 120775, 
120885-120895 and 121025. Health and Safety Code. 

History 

1 . New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

2. Repealer filed 1-8-2007 as an emergency pursuant to Health and Safety Code 
section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A 
Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emer- 
gency language will be repealed by operation of law on the following day. 

3. Repealer refiled 4-18-2007 as an emergency pursuant to Health and Safety 
Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 
16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or 
emergency language will be repealed by operation of law on the following day. 

4. Repealer refiled 8-21-2007 as an emergency pursuant to Health and Safety 
Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 
35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or 
emergency language will be repealed by operation of law on the following day. 

5. Certificate of Compliance as to 8-21-2007 order transmitted to OAL 
12-21-2007 and filed 2-6-2008 (Register 2008, No. 6). 

§ 2641.80. Personal Information. 

"Personal information" means an iBdividual's complete Social Secu- 
rity Number, complete name or surname, home address, California driv- 
er's license or identification number, electronic mail address or tele- 
phone number. 

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120 130, Health and 
Safety Code. Reference: Sections 100180, 120175. 120775, 120885-120895 and 
121025, Health and Safety Code. 

History 
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

§ 2641 .85. Publicly-Funded Confidential Counseling and 
Testing Program. 

"Publicly-funded Confidential Counseling and Testing Program" 
means a program financed by federal, state or local governmental agen- 
cies that provides confidential HIV tests to patients. 
NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and 
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 
121025, Health and Safety Code. 

History 
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

§ 2641 .90. Soundex Code. 

"Soundex code" means a phonetic, alphanumerical formula which is 
used to convert the first letter and sequential consonants of an individu- 
al's surname into an algorithm. The Soundex code instructions are identi- 
fied by the Department as form DHS 8641 SC (9/01), hereby incorpo- 
rated by reference in this Article. 

NOTE: Authority cited : Sections 1 00 1 80, 1 00275, 1 20 1 25 and 1 201 30, Health and 
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 
121025, Health and Safety Code. 

History 
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

Subarticle 4. Reporting Requirements 

§ 2643.5. HIV Reporting by Health Care Providers. 

(a) Each health care provider that orders a laboratory test used to iden- 
tify HIV, a component of HIV, or antibodies to or antigens of HIV shall 
submit to the laboratory performing the test a pre-printed laboratory req- 
uisition form which includes all documentation as specified in 42 CFR 
493. 11 05 (57 FR 7162, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 
19, 1993) and adopted in Business and Professions Code, Section 1220. 

(b) The person authorized to order the laboratory test shall include the 
following when submitting information to the laboratory: 

(1) Complete name of patient; and 

(2) Patient date of birth (2-digit month, 2-digit day, 4-digit year); and 

(3) Patient gender (male, female, transgender male-to-female, or 
transgender female-to-male); and 

(4) Date biological specimen was collected; and 

(5) Name, address, telephone number of the health care provider and 
the facility where services were rendered, if different. 



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§ 2643.10 



(c) Each health care provider shall, within seven calendar days of re- 
ceipt from a laboratory of a patient' s confirmed HIV test or determination 
hy the health care provider of a patient's confirmed HIV test, report the 
confirmed HIV test to the local Health Officer for the jurisdiction where 
the health care provider facility is located. The report shall consist of a 
completed copy of the HIV/AIDS Case Report form. 

( 1 ) All reports containing personal information, including HIV/AIDS 
Case Reports, shall be sent to the local Health Officer or his or her desig- 
nee by: 

(A) courier service, U.S. Postal Service Express or Registered mail, or 
other traceable mail; or 

(B) person-to-person transfer with the local Health Officer or his or 
her designee. 

(2) The health care provider shall not submit reports containing per- 
sonal information to the local Health Officer or his or her designee by 
electronic facsimile transmission or by electronic mail or by non-trace- 
able mail. 

(d) HIV reporting by name to the local Health Officer, via submission 
of the HIV/AIDS Case Report, shall not supplant the reporting require- 
ments in Article 1 of this Subchapter when a patient's medical condition 
progresses from HIV infection to an Acquired Immunodeficiency Syn- 
drome (AIDS) diagnosis. 

(e) A health care provider who receives notification from an out-of- 
state laboratory of a confirmed HIV test for a California patient shall re- 
port the findings to the local Health Officer for the jurisdiction where the 
health care provider facility is located. 

(f) When a health care provider orders multiple HIV-related viral load 
tests for a patient, or receives multiple laboratory reports of a confirmed 
HIV test, the health care provider shall be required to submit only one 
HIV/AIDS Case Report, per patient, to the local Health Officer. 

(g) Nothing in this Subchapter shall prohibit the local health depart- 
ment from assisting health care providers to report HIV cases. 

(h) Information reported pursuant to this Article is acquired in confi- 
dence and shall not be disclosed by the health care provider except as au- 
thorized by this Article, other state or federal law, or with the written con- 
sent of the individual to whom the information pertains or the legal 
representative of that individual. 

NOTE: Authority cited: Sections 120125, 120130, 120140, 121022, 131080 and 
13 1200. Health and Safety Code. Reference: Sections 1202.5, 1206, 1206.5, 1220, 
1241, 1265 and 1281, Business and Professions Code; and Sections 1603.1, 
101160, 120175, 120250, 120775, 120885-120895, 120917, 120975, 120980, 
121015, 121022, 121025, 121035, 121085, 131051, 131052, 131056 and 131080, 
Health and Safety Code. 

History 

1 . New subarticle 4 (sections 2643.5-2643.20) and section filed 5-2-2002; opera- 
tive 7-1-2002 (Register 2002, No. 18). 

2. Amendment of section and Note filed 1-8-2007 as an emergency pursuant to 
Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 
(Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL 
by 5-8-2007 or emergency language will be repealed by operation of law on 
the following day. 

3. Amendment of section and Note refiled 4-18-2007 as an emergency pursuant 
to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007 
(Register 2007, No. 16). A Certificate of Compliance must be transmitted to 
OAL by 9-6-2007 or emergency language will be repealed by operation of law 
on the following day. 

4. Amendment refiled 8-21-2007 with further amendment of Note as an emer- 
gency pursuant to Health and Safety Code section 121022, subdivision (c); op- 
erative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be 
transmitted to OAL by 1-7-2008 or emergency language will be repealed by 
operation of law on the following day. 

5. Certificate of Compliance as to 8-21-2007 order, including redesignation of 
former subsections (c)( 1 )A. and (c)( 1 )B. as subsections (c)( 1 )(A) and (c)(1)(B), 
transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6). 

§ 2643.10. HIV Reporting by Laboratories. 

(a) The laboratory director or authorized designee shall, within seven 
calendar days of determining a confirmed HIV test, report the confirmed 
HIV test to the Health Officer for the local health jurisdiction where the 
health care provider facility is located. The report shall include the: 

( 1 ) Complete name of patient; and 



(2) Patient date of birth (2-digit month, 2-digit day, 4-digit year); and 

(3) Patient gender (male, female, transgender male-to-female, or 
transgender female-to-male); and 

(4) Name, address, and telephone number of the health care provider 
and the facility that submitted the biological specimen to the laboratory, 
if different; and 

(5) Name, address, and telephone number of the laboratory; and 

(6) Laboratory report number as assigned by the laboratory; and 

(7) Laboratory results of the test performed; and 

(8) Date the biological specimen was tested in the laboratory; and 

(9) Laboratory Clinical Laboratory Improvement Amendments 
(CLIA) number. 

(b)( 1 ) All reports containing personal information, including laborato- 
ry reports, shall be sent to the local Health Officer or his or her designee 
by: 

(A) courier service, U.S. Postal Service Express or Registered mail, or 
other traceable mail; or 

(B) person-to-person transfer with the local Health Officer or his or 
her designee. 

(2) The laboratory shall not submit reports containing personal in- 
formation to the local Health Officer or his or her designee by electronic 
facsimile transmission or by electronic mail or by non-traceable mail. 

(c) A laboratory that receives incomplete patient data from a health 
care provider for a biological specimen with a confirmed HIV test, shall 
contact the submitting health care provider to obtain the information re- 
quired pursuant to Section 2643.5(b)(l )-(5), prior to reporting the con- 
firmed HIV test to the local Health Officer. 

(d) If a laboratory transfers a biological specimen to another laboratory 
for testing, the laboratory that first receives the biological specimen from 
the health care provider shall report confirmed HIV tests to the local 
Health Officer. 

(e) Laboratories shall not submit reports to the local health department 
for confirmed HIV tests for patients of an Alternative Testing Site or oth- 
er anonymous HIV testing program, a blood bank, a plasma center, or for 
participants of a blinded and/or unlinked seroprevalence study. 

(f) When a California laboratory receives a biological specimen for 
testing from an out-of-state laboratory or health care provider, the 
California director of the laboratory shall ensure that a confirmed HIV 
test is reported to the state health department in the state where the biolog- 
ical specimen originated. 

(g) When a California laboratory receives a report from an out of state 
laboratory that indicates evidence of a confirmed HIV test for a Califor- 
nia patient, the California laboratory shall notify the local Health Officer 
and health care provider in the same manner as if the findings had been 
made by the California laboratory. 

(h) Information reported pursuant to this Article is acquired in confi- 
dence and shall not be disclosed by the laboratory except as authorized 
by this Article, other state or federal law, or with the written consent of 
the individual to whom the information pertains or the legal representa- 
tive of the individual. 

NOTE: Authority cited: Section 1224, Business and Professions Code; and Sec- 
tions 120125, 120130, 120140, 121022. 131080 and 131200, Health and Safety 
Code. Reference: Sections 1206, 1206.5. 1209, 1220, 1241, 1265, 1281 and 1288, 
Business and Professions Code; and Sections 101150, 120175, 120775, 
120885-120895, 120975, 120980. 121022, 121025, 121035, 131051, 1310.52, 
131056 and 131080, Health and Safety Code. 

History 

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

2. Amendment of section and Note filed 1-8-2007 as an emergency pursuant to 
Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 
(Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL 
by 5-8-2007 or emergency language will be repealed by operation of law on 
the following day. 

3. Amendment of section and Note refiled 4-18-2007 as an emergency pursuant 
to Health and Safety Code section 121022, subdivision (c): operative 5-9-2007 
(Register 2007, No. 16). A Certificate of Compliance must be transmiued to 
OAL by 9-6-2007 or emergency language will be repealed by operation of law 
on the following day. 

4. Amendment refiled with further amendment of Note 8-21-2007 as an emer- 
gency pursuant to Health and Safety Code section 121022, subdivision (c); op- 



Page 76.5 



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§ 2643.15 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



crativc 9-7-2007 (Register 2007, No. ?5). A Certificate of Compliance must be 
transmitted to OAL by 1-7-2008 or emergency language will be repealed by 
operation of law on the following day. 

3. Certificate of Compliance as to 8-21-2007 order, including redesignation of 
former subsections (b)(l)A. and (b)(l iB. as subsections (b)(1)(A) and 
(b)( 1 )(B), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Reaister 2008, 
No. 6). 

§ 2643.15. HIV Reporting by Local Health Officers. 

(a) The local Health Officer or his or her authorized designee shall 
match and unduplicate laboratory reports of confirmed HIV tests with the 
local health department HIV/AIDS registry database and with HIV/ 
AIDS Case Reports received from health care providers and not entered 
into the database. 

(b) The Health Officer or his or her authorized designee shall, within 
45 calendar days of receipt of a laboratory report of a confirmed HIV test, 
submit unduplicated HIV/AIDS Case Reports to the Department. 

( 1 ) HIV/AIDS Case Reports shall be sent by courier service, U.S. Post- 
al Service Express or Registered mail, or other traceable mail to the 
California Department of Public Health, Office of AIDS, HIV/AIDS 
Case Registry. 

(2) The local Health Officer or his or her authorized designee shall not 
report confirmed HIV tests for patients of an Alternative Testing Site or 
other anonymous counseling and testing program, a blood bank, a plasma 
center, or for participants of a blinded and/or unlinked HIV seropreva- 
lence study. 

(c) The local Health Officer or his or her authorized designee shall not 
submit an HIV/AIDS Case Report to the Department for an infant under 
the age of 18 months, unless the infant's HIV infection is confirmed. 

(d) All local health department employees and contractors shall sign 
the HIV/AIDS Confidentiality Agreement prior to accessing confiden- 
tial HIV-related public health records. All HIV/AIDS Confidentiality 
Agreements shall be renewed at least once per year. 

(e) Information reported pursuant to this Article is acquired in confi- 
dence and shall not be disclosed by the local Health Officer or his or her 
authorized designee except as authorized by this Article, other state or 
federal law, or with the written consent of the individual to whom the in- 
formation pertains or the legal representative of the individual. 
NOTE; Authority cited: Sections 120125, 120130, 120140, 121022, 131080 and 
131200, Health and Safety Code. Reference: Sections 120175, 120775, 120820, 
120885-120895, 120975, 120980, 121015, 121022, 121025, 121035, 121085, 
131019, 131051, 131052, 131056 and 131080, Health and Safety Code. 

History 

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 

2. New subsection (d), subsection relettering and amendment of Note filed 
1-8-2007 as an emergency pursuant to Health and Safety Code section 121022, 
subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A Certificate of 
Compliance must be transmitted to OAL by 5-8-2007 or emergency language 
will be repealed by operation of law on the following day. 

3. New subsection (d), subsecfion relettering and amendment of NOTE refiled 
4-18-2007 as an emergency pursuant to Health and Safety Code section 
121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). ACertifi- 
cate of Compliance must be transmitted to OAL by 9-6-2007 or emergency lan- 
guage will be repealed by operation of law on the following day. 

4. New subsection (d), subsection relettering and amendment of Note refiled with 
further amendment of Note 8-21-2007 as an emergency pursuant to Health and 
Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 
2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 
1-7-2008 or emergency language will be repealed by operation of law on the 
following day. 

5. Certificate of Compliance as to 8-21-2007 order, including further amendment 
of subsection (b)(1), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Reg- 
ister 2008, No. 6). 

§ 2643.20. HIV Reporting Exemptions. 

Alternative Testing Sites; other anonymous or unlinked HIV testing 
programs; blood banks; plasma centers; and blinded and/or unlinked ser- 
oprevalence studies are exempt from these HIV reporting regulations. 
NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and 
Safety Code. Reference: Secdons 100180, 120175, 120775, 120885-120895 and 
121025, Health and Safety Code. 

History 
1. New secfion filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18). 



Article 4. Approval Procedures for Canine 
Rabies Vaccines 

§ 2650. Canine Rabies Vaccine Advisory Committee. 

The Director shall appoint a Canine Rabies Vaccine Advisory Com- 
mittee consisting of 6 to 8 members. The Committee's responsibility 
shall be to assist the Department in evaluating the effectiveness of canine 
rabies vaccines. Membership shall include individuals with recognized 
professional expertise in at least one of the fields of immunology, virolo- 
gy, epidemiology, public health and veterinary medicine. Committee 
members shall serve without compensation but shall be reimbursed for 
actual and necessary expenses incurred during service on the committee. 
Canine rabies vaccines that have been approved by the Animal and Plant 
Health Inspection Service (APHIS), U.S. Department of Agriculture, 
shall be evaluated for the degree of effectiveness by the Canine Rabies 
Vaccine Advisory Committee. In order to evaluate vaccine effectiveness 
the committee shall: 

(a) Review test data submitted by canine rabies vaccine manufacturing 
firms, for approval of canine rabies vaccines. 

(b) Make recommendations for Departmental approval or disapproval 
of canine rabies vaccines. 

(c) Make recommendations concerning approval of any variances 
from the established standards for acceptance of canine rabies vaccines. 
NOTE: Authority cited: Section 1920(b), Health and Safety Code. Reference: Sec- 
tion 1920(b), Health and Safety Code. 

History 
1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44). 

§ 2651 . Approval of Canine Rabies Vaccines. 

(a) In order for a canine rabies vaccine to be approved for use in Cali- 
fornia, it shall adhere to the following requirements: 

(1) Meet Animal and Plant Health Inspection Service (APHIS) stan- 
dards for sterility and safety. Evidence of product conformance to APHIS 
Standards will be demonstrated by the United States Department of Agri- 
culture (USDA) product licensing; and 

(2) If an inactivated vaccine, it shall have a minimal relative potency 
(RP) at vaccination of at least 2.0 as determined by the National Institute 
of Health (NIH)Test for potency or if a modified live virus (MLV) vac- 
cine it shall meet USDA potency Requirements; and 

(3) Demonstrate an immunity duration of three or more years based on 
an immunity duration challenge study conducted in conformity with sec- 
tion 2652; and 

(4) Comply with the origin and integrity of Rabies Vaccine Virus Re- 
quirements in section 2653. 

NOTE: Authority cited: Section 1920(b), Health and Safety Code. Reference: Sec- 
tion 1920(b), Health and Safety Code. 

History 
1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44). 

§ 2652. Immunity Duration-Challenge Studies. 

(a) The demonstration of an acceptable immunity duration of three or 
more years, as shown by adequate challenge studies in dogs, shall be re- 
quired. However, the above challenge study shall not suffice for accep- 
tance of a subsequent multiple vaccine product that contains the same ra- 
bies vaccine as one of two or more component vaccines. 

(b) Vaccine Trial Protocols. Vaccine trial protocols shall be submitted 
to the Department by vaccine manufacturers prior to beginning the im- 
munity duration challenge study. The protocol shall include animals, ma- 
terials, methods and procedures. The protocol shall include the identifi- 
cation number of each animal, its source and/or that of its mother, if 
applicable, sex, age, breed and the name, address, and telephone number 
of a contact person who can verify personal knowledge of the dog' s vac- 
cination history. Annual progress reports and a final report of the 
immunity-duration challenge study shall be submitted to the Depart- 
ment. The reports shall include by date for each dog its rabies antibody 
titers, other immunizations, medications, illnesses, unusual events and 
death, if applicable, as well as any changes or developments in reference 



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§2653 



to animals, materials, methods, and procedures. The Department shall 
supply firms with an outline to report the foregoing information. The out- 
line will include the following items: 

( 1 ) "Protocol for Proposed Rabies Vaccine Immunity Duration Chal- 
lenge Study"; 

(2) "Procedures and Preliminary Data Attending Initiation of Canine 
Rabies Vaccine Immunity Duration Challenge Study"; 

(3) "Progress Report: One Year Postvaccination"; 

(4) "Progress Report: Two Years Postvaccination"; 

(5) "Final Report"; 

(6) "Results of Challenge"; and 

(7) "Progress Report for Three Years Postvaccination." 

The Veterinary Public Health Unit, 714 P Street, Room 760, Sacra- 
mento. California 95814 will provide this outline upon request. 

(c) Dogs Used in Studies. No pound dogs or other dogs of undetermin- 
able rabies vaccination history shall be used in the study. Dogs shall be 
obtained from the original owner since birth or have verifiable histories. 
Groups of vaccinates and control dogs shall be of approximately equal 
composition, according to numbers, sex ratio (approximately 50:50), 
age, and origin. As much as is possible, dogs of uniform size or confor- 
mation shall be used. No dog shall be used which has had prior rabies im- 
munization or which has detectable serum rabies neutralizing antibodies. 
Dogs under 8 months of age used in studies shall not originate from 
rabies-immunized mothers. No dog shall be over 1 1/2 years of age at 
vaccination or when set aside as a control. 

(d) Size of Challenge Groups. Challenge groups, both vaccinates and 
nonimmunized controls, shall each consist of 30 or more dogs at chal- 
lenge. Any additional (extra or back-up) dogs, intended to replace vacci- 
nates or controls that die prior to challenge, shall be included in either the 
vaccinate or the control group prior to the initiation of the study and sub- 
sequently treated, sampled and reported on as either a vaccinate dog or 
as a control dog. The use of additional sets of vaccinate and/or control 
dogs to be challenged simultaneously, or at an earlier or later date, shall 
not be recognized as representative of separate trials. Instead, the sero- 
logical results subsequent to vaccination and the reactions to challenge 
of all groups, sets, and individual dogs shall be included in the overall 
analysis on a cumulative basis. Failed antibody response or failed reac- 
tion to challenge at any time shall disqualify subsequent trial phases. 

(e) Route and Site of Vaccination. MLV vaccines shall be inoculated 
intramuscularly at one site in the thigh. Inactivated vaccines may be in- 
oculated by any single route and single site which provides the required 
protection against challenge at least 3 years post vaccination and is 
shown to be safe. The exact site and route of inoculadon shall be de- 
scribed. 

(f) New Route and/or Site of Vaccination. If a firm changes its recom- 
mended route and/or site of vaccination of a previously approved vac- 
cine, the vaccine shall be tested as a new product, and the firm shall com- 
plete another satisfactory immunity duration-challenge study of 3 years 
or greater duration before the new route and/or site of vaccination shall 
be approved. 

(g) Additional Vaccinations. Excepting food and water, no vaccinate 
or control dog shall be exposed to any vaccine, drug, or other substance 
by any route within three weeks prior to any bleeding for antibody test 
or within three weeks prior to or at any time after challenge with rabies 
virus except at euthanasia. 

(h) Serology. Standard serum virus-neutralization tests done in mice 
(MSNT) or the rapid rabies fluorescent focus inhibition test (RFFIT) 
shall be used in comparing the immunogenicity of different products. No 
substitute test reagents or substitute tests shall be accepted. 

( 1 ) Test results shall be reported for the vaccinate group and controls. 
Serum virus-neutralization titrations shall be performed on sera of ( 1 ) all 
dogs prior to vaccinadon; (2) vaccinates at the end of post vaccination 
months 1 , 3, 6, 9, 1 2, 1 8, 24, 30 and 36 just prior to challenge; (3) controls 
at the end of month 36 just prior to challenge; and (4) survivors just prior 
to euthanasia. 



(2) At years post vaccination, all vaccinate dogs shall have demon- 
strable serum rabies antibody titers, the median titer being equal to, or 
greater than. 1 : 15 by the MSNT or an equivalent test. 

(3) At 3 years post vaccination, at least 90 per cent of vaccinates shall 
have demonstrable titers by the MSNT, the median titer being equal to, 
or greater than, 1 : 10 by the MSNT or an equivalent test. 

(i) Incidental Deaths or Deletions. There shall be a complete account- 
ing for all dogs used in the study, including any that die or are killed after 
the start of the study or any withdrawn from participation for any reason. 
Each such dog shall be accounted for by dates and details of illness, treat- 
ment and death, the cause of death with supportive diagnostic test results, 
and rabies serology records. Each such dog shall be tested for rabies in- 
fection by Fluorescent Rabies Antibody (ERA) test followed by the 
mouse inoculation test if the FRA test is negative. 

(j) Challenge Virus and Dose. The challenge virus inoculum shall be 
infective carnivore salivary gland suspension supemate of a North Amer- 
ican carnivore "street" rabies virus. The dose of challenge virus given 
shall be estimated by titration prior to challenge and confirmed by titra- 
tion of residual challenge inoculum. The dose of challenge virus shall be 
as low as possible while still achieving a mortality of 80-100 per cent 
in controls. The dose given each dog shall not exceed 200,000 mouse in- 
tracranial 50 percent lethal doses (MICLD50), or a demonstrably equiva- 
lent dose as determined by an alternate method of titration. 

(k) Challenge Route and Procedure. Only challenge virus inoculum 
shall be inoculated into the masseter muscles of vaccinate dogs or control 
dogs at any time. Challenge virus shall be inoculated intramuscularly into 
the masseter muscles, the viral dose being divided into two equal parts 
for bilateral inoculation. Should a challenge route or site other than the 
intramasseter route be used, the firm employing the route or site shall 
demonstrate in a trial previously approved by the Department, the effec- 
tiveness and appropriateness of the post challenge holding period and 
compensate for any related increase in incubation period and decrease in 
susceptibility. All animals, vaccinates and controls, shall be challenged 
at the same time, either on an alternate basis (i.e., a vaccinate, followed 
by a control, followed by a vaccinate, etc.) or the vaccinates shall be chal- 
lenged first and the controls challenged immediately afterwards. A sepa- 
rate needle and a separate syringe shall be used for each dog. 

(1) Individual Enclosure for Each Challenged Dog. Each dog shall be 
kept in an individual enclosure, preventing its contact with any other ani- 
mal. 

(m) Post challenge Observation Period. Challenged dogs, retained in 
isolation, shall be observed for a minimum of 90 days prior to final bleed- 
mg, euthanasia, and rabies testing of their brains. 

(n) Mortality in Challenged Animals. With rare exceptions, all vacci- 
nates shall survive challenge. Eighty to one hundred percent of chal- 
lenged controls shall die of rabies. 

(o) Confirmatory Rabies Diagnostic Tests on Brains of Dogs that Die 
and on Brains of Survivors. Brains of dogs that die and brains of dogs that 
survive challenge shall be tested by fluorescent rabies antibody (FRA) 
test, followed by mouse-inoculation test if the former is negadve; dead 
mice shall be confirmed as rabies-infected by FRA test on their brains. 
Dogs that die at any dme following administration of a live virus vaccine 
shall be tested for possible rabies vaccine virus infection, using tests suit- 
able to disclose, recover, and identify the strain of vaccine virus. 
NOTE: Authority cited: Section 1920(b), Health and Safety Code. Reference: Sec- 
tion 1920(b), Health and Safety Code. 

History 

1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44). 

§ 2653. Origin and Integrity of Rabies Vaccine Virus. 

The Department shall be provided with comprehensive information on 
the origin, passage level, and sub-passage history of rabies viruses used 
in the development and production of rabies vaccines being submitted for 
approval. The integrity of the rabies virus used in the production of the 
vaccine shall be maintained without further modification once the \ ae- 
cine is approved for use in the Department's rabies control program. 



Page 76.7 



Register 2008, No. 6; 2-8-2008 



§2800 



BARCLAYS CALIFORNIA CODE OF REGULATIONS 



Title 17 



NOTI:; Authority cited: Section 1920(b), Healtli and Safety Code. Reference: Sec- 
tion 1920(b), Health and Safety Code. 

History 
1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44). 



Subchapter 2. Adult Health 

History 
Repealer of Subchapter 2 (Sections 2700, 2705, 2710 and 271 1 ) filed 9-27-85; 
effective thirtieth day thereafter (Register 85, No. 39). For prior history, see 
Register 58, No. 10. 



Subchapter 2.5. Disorders Characterized 
by Lapses of Consciousness 



Article 1. Definitions 

§ 2800. Activities of Daily Living. 

"Activities of daily living" means bathing, dressing, feeding oneself, 
brushing one's teeth, and performing more complex tasks such as gro- 
cery shopping, cooking, management of personal finances, and operat- 
ing a motor vehicle. 

Note: Authority cited: Sections 100275 and 1039QO, Health and Safety Code. 
Reference: Section 103900, Health and Safety Code. 

History 

1. New subchapter 2.5 (articles 1-2, sections 2800-2812), article 1 (secdons 
2800-2808) and section filed 5-17-2000; operative 10-2-2000 (Register 2000, 
No. 20). 

§ 2802. Alzheimer's Disease and Related Disorders. 

"Alzheimer's disease and related disorders" means those illnesses that 
damage the brain causing irreversible, progressive confusion, disorienta- 
tion, loss of memory and judgment. 

NOTE: Authority cited: Sections 100275 and 103900, Health and Safety Code. 
Reference: Section 103900, Health and Safety Code. 

History 
1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20). 

§ 2804. Diagnose. 

"Diagnose" means to identify the existence of a medical condition in 
a patient. 

Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. 
Reference: Section 103900, Health and Safety Code. 

History 
1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20). 

§ 2806. Disorders Characterized by Lapses of 
Consciousness. 

(a) "Disorders characterized by lapses of consciousness" means those 
medical conditions that involve: 

( 1 ) a loss of consciousness or a marked reduction of alertness or re- 
sponsiveness to external stimuli; and 

(2) the inability to perform one or more activities of daily living; and 

(3) the impairment of the sensory motor functions used to operate a 
motor vehicle. 

(b) Examples of medical conditions that do not always, but may prog- 
ress to the level of functional severity described in subsection (a) of this 
section include Alzheimer's disease and related disorders, seizure disor- 
ders, brain tumors, narcolepsy, sleep apnea, and abnormal metabolic 
states, including hypo- and hyperglycemia associated with diabetes. 
NOTE; Authority cited: Sections 100275 and 103900, Health and Safety Code. 
Reference: Section 103900, Health and Safety Code. 

History 
1. New section